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Gynecology Trials 
TITLE GOG 0129P: A Phase II Evaluation on Ixabepilone (BMS-247550) in the Treatment of Recurrent or Persistent Endometrial Carcinoma
DESCRIPTION This study will determine if patients respond when treated with ixabepilone for recurrent or persistent endometrial cancer. Patients will receive ixabepilone on the first day of every 21-day cycle until the disease progresses or there are unacceptable side effects. 
ELIGIBILITY
  1. Patients must have recurrent or persistent endometrial adenocarcarcinoma not amenable to management with surgery, radiation or higher priority or standard chemotherapy
  2. Must have a GOG performance status of 0-2
  3. Must have adequate or better bone marrow, kidney, and liver function
  4. Must have adequate sensory or motor neuropathy ≤ grade 1
  5. Cannot have an active infection requiring antibiotics
  6. Cannot have had prior biologic or immunologic agents directed at the malignant tumor within 3 weeks of study
  7. Can have one prior non-cytotoxic (biologic or cytostatic) regimen for management of recurrent or persistent disease (includes, but is not limited to monoclonal antibodies, cytokines, or small-molecule inhibitors of signal transduction). Cannot have had more than 1 prior cytotoxic chemotherapy regimen (either single or combination drug therapy)
  8. Must not have received prior ixabepilone but can have received prior paclitaxel or docetaxel
CONTACT Nancy Fusco, RN 216-844-1661
TITLE GOG 232B: Phase II Study of 3-AP and Cisplatin in Patients with Recurrent or Persistent Platinum-Resistant Ovarian Epithelial or Primary Peritoneal Cancer
DESCRIPTION This study will estimate the ability of carboplatin plus paclitaxel to control tumor growth in patients with recurrent or advanced uterine carcinosarcomas. Patients will receive chemotherapy on the first day of each 21-day time period (or cycle). As part of this chemotherapy, patients will receive the drug paclitaxel by vein over a period of 3 hours. Next they will receive the drug carboplatin, by vein, over a period of approximately 30 minutes. This treatment is done at an outpatient chemotherapy clinic or doctor’s office and will take a total of 4-6 hours at each visit. 
ELIGIBILITY
  1. Patients must have advanced (stage III or IV), persistent or recurrent uterine carcinosarcoma (mixed mesodermal tumor [MMT] with documented disease progression
  2. Must have disease that can be measured with at least one lesion > 20 mm when measured by conventional techniques, or > 10 mm when measured by spiral CT; must have at least one “target lesion” as defined by RECIST (tumors within a previously irradiated field will be designated as “non-target” lesions)
  3. Must have recovered from effects of recent surgery, radiotherapy or other therapy
  4. Should be free of active infection requiring antibiotics and have no lung disease requiring oxygen
  5. Must have discontinued any hormonal therapy directed at the malignant tumor at least one week prior to registration
  6. Must have adequate bone marrow function, kidney, liver, and neurological function
  7. Must be 18 years of age or older.
CONTACT Nancy Fusco, RN 216-844-1661
TITLE GOG 0126O: A Phase II Study of Triapine and Cisplatin in the Treatment of Recurrent or Persistent Ovarian Carcinoma.
DESCRIPTION This study will determine how well Triapine (3-AP) together with cisplatin works in controlling the growth of tumors in patients with recurrent or persistent platinum-resistant ovarian epithelial cancer or primary peritoneal cancer. Patients will receive 3-AP on each of the first four days of 21-day cycles, and cisplatin on the second and third day of the cycles. 
ELIGIBILITY
  1. Must have histologically confirmed ovarian epithelial or primary peritoneal cancer with recurrent or persistent disease, and at least 1 uni-dimensionally target lesion that measures at least 20 mm by conventional techniques or at least 10 mm by spiral CT scan
  2. Must be 18 years of age or older
  3. Must have adequate absolute bone marrow, liver and kidney function
  4. Must not have any serious cardiac disease, history of myocardial infarction, and uncontrolled congestive heart failure, or pulmonary disease requiring oxygen
  5. Cannot have active infections requiring antibiotics 
  6. Cannot have prior radiotherapy to more than 25% of marrow-bearing areas
CONTACT Nancy Fusco, RN 216-844-1661
TITLE GOG 0229D A Phase II Evaluation of Lapatinib (GW572016) in the Treatment of Persistent or Recurrent Endometrial Carcinoma
DESCRIPTION This study is being done to estimate the probability of surviving progression-free for at least six months after initiating therapy with lapatinib for patients with recurrent or persistent endometrial cancer. The drug, lapatinib, will be given orally in pill form (six pills per day) everyday on an outpatient basis. One cycle will be 28-days. 
ELIGIBILITY
  1. Patients must have a confirmed diagnosis of recurrent or persistent endometrial carcinoma.
  2. Patients must have measurable disease.
  3. Patents must have at least one “target lesion” to assess response on this study as defined by RECIST.
  4. Patients must have recovered from the effects of recent surgery, radiotherapy or chemotherapy.
  5. Patients must not be eligible for a higher priority GOG study.
  6. Patients who have had one prior regimen must have a GOG performance status of 0,1, or 2.
  7. Patients must have had one prior chemotherapeutic regimen for the management of endometrial carcinoma.
  8. Patients are allowed to receive, but are not required to receive, one additional cytotoxic regimen for the management of their disease.
  9. Patients may not have received any non-cytotoxic chemotherapy for the management of their disease.
  10. Patients must have adequate bone marrow, kidney, liver and neurologic function.
CONTACT Nancy Fusco, RN 216-844-1661
TITLE GOG 0188 A Phase II Study of Faslodex® in Recurrent/Metastatic Endometrial Cancer
DESCRIPTION This study is being done to estimate the probability of clinical response to the drug Faslodex® in patients with persistent or recurrent endometrial cancer. The drug, Faslodex®, will be given intramuscularly (IM) every 28 days (1 cycle is defined as one IM injection of the drug). The minimum planned treatment period will be 2 cycles. 
ELIGIBILITY
  1. Patients must have a confirmed diagnosis of recurrent, persistent or metastatic endometrial cancer that is not curable with either surgery or radiation therapy.
  2. Patients must have at least one “target lesion” to be used to assess response on this study as defined by RECIST.
  3. Patients must have a GOG performance status of 0 or 1.
  4. Patients must have adequate bone marrow, kidney, and liver function.
  5. Patients may have received prior surgery, radiation therapy or hormonal treatment.
CONTACT Nancy Fusco, RN 216-844-1661
TITLE GOG 0229C A Phase II Trial of ZD1839 (Iressa) in the Treatment of Persistent or Recurrent Endometrial Carcinoma
DESCRIPTION This study is being done to estimate the probability of surviving progression-free at 6 months for patients with advanced or recurrent endometrial cancer who have failed on higher priority treatment studies. Patients will receive the drug, ZD1839 (Iressa), orally on a daily basis. Each 28 day period will be considered a cycle.
ELIGIBILITY
  1. Patients must have a confirmed diagnosis of recurrent or persistent endometrial carcinoma.
  2. Patients must have measurable disease.
  3. Patients must have one “target lesion” to be used to assess response on this protocol as defined by RECIST. 
  4. Patients must not be eligible for a higher priority GOG protocol.
  5. Patients who have received one prior regimen must have a GOG performance status of 0, 1, or 2.
  6. Patients must have recovered from the effects of recent surgery, radiotherapy, or chemotherapy.
  7. Patients must have had one prior chemotherapeutic regimen for the management of endometrial carcinoma.
  8. Patients are allowed to receive, but are not required to receive, one additional cytotoxic regiment for the management of their disease.
  9. Patient must not have received any non-cytotoxic chemotherapy for management of recurrent or persistent disease.
  10. Patients must have adequate bone marrow, kidney, liver and neurologic function.
CONTACT Nancy Fusco, RN 216-844-1661
TITLE GOG 0198 A Randomized Study of Tamoxifen versus Thalidomide in Patients with Biochemical Recurrence Only Epithelial Ovarian Cancer, Cancer of the Fallopian Tube, and Primary Peritoneal Carcinoma after First Line Chemotherapy
DESCRIPTION This study is being done to compare the recurrence –free survival of women receiving tamoxifen or thalidomide for epithelial ovarian cancer, cancer of the fallopian tube, or primary peritoneal cancer who are in complete clinical remission following front-line treatment but have a high risk of recurrence due to rising CA-125. Patients will receive a capsule of thalidomide orally at bedtime each day with weekly dose escalation up to study limit or patient develops dose limiting toxicity. 
ELIGIBILITY
  1. Patients must have a confirmed diagnosis of epithelial ovarian cancer, tubal cancer, or primary peritoneal cancer and have received only one first-line chemotherapy regimen (platinum/taxane based).
  2. Patients must be clinical and radiologically without evidence of measurable and non-measurable disease.
  3. Patient’s CA-125 must be normal prior to or during first -line chemotherapy.
  4. Patients must not be eligible for higher priority GOG protocol.
  5. Patients must have a GOG performance status of 0-1.
  6. Patients must have recovered from effects of recent surgery, chemotherapy, and/or radiotherapy and be free of significant infection.
  7. Patients must have adequate bone marrow, kidney, liver and neurologic function.
CONTACT Nancy Fusco, RN 216-844-1661
TITLE GOG 0212 A Randomized Phase III Trial of Maintenance Chemotherapy Comparing 12 Monthly Cycles of Single Agent Paclitaxel or Xyotax (CT-2103) versus No Treatment until Documented Relapse in Women with Advanced Ovarian or Primary Peritoneal Cancer Who Achieve a Complete Clinical Response to Primary Platinum/Taxane Chemotherapy
DESCRIPTION This study is being done to determine whether the drug Xyotax™ or paclitaxel given to women with advanced ovarian cancer, who have attained a clinically defined complete response to primary platinum/taxane-based chemotherapy, will reduce the death rate compared to re-treatment at the time of documented disease progression. After receiving 4 to 6 cycles of platinum-taxane therapy, patients will be randomized into one of 3 treatment arms. The first treatment arm will consist of the drug Xyotax™ given once each month for 12 months. In the second arm of the study patients will be given a single agent, paclitaxel; and in the third arm of the study patients will receive no treatment. 
ELIGIBILITY
  1. Patients must have a confirmed diagnosis of primary peritoneal carcinoma or epithelial ovarian carcinoma, Stage III or IV, with either optimal or suboptimal residual disease following initial surgery.
  2. Patients must have completed treatment within the past 6 weeks with at least 5 cycles and not more than 6 cycles of carboplatin (IV or IP) and paclitaxel or docetaxel-based combination chemotherapy and have no symptoms suggestive of persistent cancer.
  3. Patients must have adequate bone marrow, kidney, liver and neurologic function.
  4. Patients must have a GOG performance status of 0, 1, or 2.
CONTACT Nancy Fusco, RN 216-844-1661
TITLE GOG 0230C A Phase II Evaluation of Gleevec (Imatinib Mesylate) in the Treatment of Recurrent or Persistent Carcinosarcoma of the Uterus
DESCRIPTION This study is being done to determine the activity of the drug Gleevec™ (imatinib mesylate) as measured by progression-free survival at six months in patients with persistent carcinosarcoma of the uterus. Gleevec will be given once a day orally (a cycle is defined as 28 days). 
ELIGIBILITY
  1. Patients must have a confirmed diagnosis of uterine cancer that is persistent or recurrent with documented disease progression after appropriate local therapy.
  2. All patients must have measurable disease.
  3. Patients must have at least one “target lesion” to be used to assess response on this study as defined by RECIST.
  4. Patients must not be eligible for a higher priority GOG protocol, if one exists.
  5. Patients who have received one prior regimen must have a GOG performance status of 0, 1, or 2.
  6. Patients must have recovered from the effects of recent surgery, radiotherapy, or chemotherapy and be free of active infection requiring antibiotics.
  7. Patients must have had one prior chemotherapeutic regimen for the management of carcinosarcoma.
  8. Patients are allowed to receive, but not required to receive, once additional cytotoxic regimen for the management of recurrent or persistent disease according to study parameters.
  9. Patients must not have received any non-cytotoxic chemotherapy for management of recurrent or persistent disease.
  10. Patients must have adequate bone marrow, liver, kidney, and neurologic function.
CONTACT Nancy Fusco, RN 216-844-1661
TITLE CASE 2804: A Phase II Randomized Trial of BAY-43-9006, a Novel RafKinase Inhibitor, versus BAY 43-9006 plus Paclitaxel/Carboplatin in Women with Recurrent Platinum Sensitive Epithelial Ovarian, Peritoneal or Fallopian Tube Cancer
DESCRIPTION This study will compare the progression-free survival rate of single agent BAY 43-9006 to that of the combination of BAY 43-9006 plus carboplatin and paclitaxel. Patients will be randomized to one of two arms. Patients in Arm A will receive oral BAY 43-9006 twice daily. Patients in Arm B will receive IV carboplatin and paclitaxel on day 1 every 21 days. Patients will also receive oral BAY 43-9006 twice daily on days 2-19. Patients in both arms will be reassessed for response and those with complete response, partial response or stable disease will be allowed to continue on study.
ELIGIBILITY
  1. Patients with recurrent epithelial ovarian cancer, primary peritoneal or fallopian tube cancer that is considered platinum sensitive will be eligible for this trial.
  2. Patients must have measurable disease that is not in a previously irradiated field.
  3. Patients must have received prior therapy with a platinum-based regimen before study enrollments but must not have had more than 2 chemotherapy regimens, and must be platinum sensitive. Prior hormonal therapy is allowed.
  4. Patients must have a life expectancy of greater than 12 weeks.
  5. Patients must have normal liver, kidney and bone marrow function.
CONTACT Nancy Fusco, RN 216-844-1661
TITLE GOG 9917: A Dose-Escalating Phase I Study with an Expanded Cohort to Assess the Feasibility of Intraperitoneal Carboplatin and Intravenous Paclitaxel in Patients with Previously Untreated Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Carcinoma
DESCRIPTION This study will determine the maximum tolerated dose of intraperitoneal carboplatin in combination with intravenous paclitaxel during the first cycle of treatment in patients with chemo-naďve ovarian, primary peritoneal or fallopian tube cancer. Treatment will consist of intraperitoneal carboplatin with intravenous paclitaxel every 21 days for a maximum of 8 cycles.
ELIGIBILITY
  1. Patients must have a histologic diagnosis of epithelial ovarian, primary peritoneal or fallopian tube carcinoma, Stage III or IV, with either optimal (< 1 cm residual disease) or suboptimal residual disease following initial surgery. Must be no more than 12 weeks postoperatively.
  2. Must have a GOG performance status of 0-2.
  3. Patients must have adequate bone marrow, kidney, liver, and neurologic function.
  4. Patients must not have received any prior treatment other than surgery.
  5. Must not have an active infection or active bleeding.
  6. Patients must not have unstable angina or have had a myocardial infarction in the past 6 months. Patients with evidence of cardiac conduction abnormalities are eligible if their cardiac status has been stable for 6 months.
  7. Patients with synchronous primary endometrial cancer, or past history of endometrial cancer are not eligible unless 1) the stage is not greater than IB, 2) the cancer has less than a 3 mm invasion without vascular or lymphatic invasion, or 3) the cancer is not of a poorly differentiated subtype.
  8. Must not have had a history of other invasive malignancies within the last 5 years with the exception of non-melanoma skin cancer and localized breast cancer. 
CONTACT Nancy Fusco, RN 216-844-1661
TITLE GOG 0181B: A Phase II Evaluation of Trastuzumab in Patients with Advanced, Recurrent or Persistent Endometrial Carcinoma with or without Prior Chemotherapy
DESCRIPTION This study will estimate the anti-tumor activity of trastuzumab with response in patients with advanced, recurrent or persistent endometrial adenocarcinomas. Trastuzumab will be given weekly.
ELIGIBILITY
  1. Patients must have advanced, recurrent or persistent endometrial carcinoma which is refractory to curative therapy. Disease must demonstrate HER2/neu gene amplification by FISH assay.
  2. Must have a GOG performance status of 0-2.
  3. Patients must have adequate bone marrow, kidney, liver, heart and lung function.
  4. Must have recovered from effects of recent surgery, radiotherapy or chemotherapy.
  5. Patients must have measurable disease.
  6. Must be free of active infection.
  7. Patients must not have unstable angina or have had a myocardial infarction in the past 6 months. Patients with evidence of cardiac conduction abnormalities are eligible if their cardiac status has been stable for 6 months.
  8. Must not have had a history of other invasive malignancies within the last 5 years with the exception of non-melanoma skin cancer.
  9. Must not have an unstable medical condition or require supplemental oxygen. 
CONTACT Nancy Fusco, RN 216-844-1661
TITLE GOG 0126Q: A Phase II Evaluation of Pemetrexed (Alimta, LY231514) in the Treatment of Recurrent or Persistent Platinum-Resistant Ovarian or Primary Peritoneal Carcinoma
DESCRIPTION This study will estimate the antitumor activity of Pemetrexed in patients with persistent or recurrent platinum-resistant ovarian or primary peritoneal cancer who have treatment on other higher priority studies. Pemetrexed will be given every 21 days.
ELIGIBILITY
  1. Patients must have recurrent or persistent ovarian or primary peritoneal cancer. Must have had one prior platinum-based chemotherapy regimen containing carboplatin, cisplatin or other organoplatinum compound. 
  2. Must have measurable disease.
  3. Must have a GOG performance status of 0-2.
  4. Patients must have adequate bone marrow, kidney, liver, and neurologic function.
  5. Must have recovered from effects of recent surgery, radiotherapy or chemotherapy.
  6. Patients must not have an active infection.
  7. Must not have had a history of other invasive malignancies within the last 5 years with the exception of non-melanoma skin cancer.
CONTACT Nancy Fusco, RN 216-844-1661
TITLE GOG 0127T: A Phase II Evaluation of Pemetrexed (Alimta, LY231514) in the Treatment of Recurrent Carcinoma of the Cervix
DESCRIPTION This study will estimate the antitumor activity of Pemetrexed in patients with recurrent carcinoma of the cervix who have failed treatment on higher priority studies. Pemetrexed will be given every 21 days.
ELIGIBILITY
  1. Patients must have recurrent carcinoma of the cervix with documented disease progression. Must have had one prior chemotherapy regimen for management of persistent or recurrent carcinoma of the cervix.
  2. Must have measurable disease.
  3. Must have a GOG performance status of 0-2.
  4. Patients must have adequate bone marrow, kidney, liver, and neurologic function.
  5. Must have recovered from effects of recent surgery, radiotherapy or chemotherapy.
  6. Patients must not have an active infection.
  7. Must not have had a history of other invasive malignancies within the last 5 years with the exception of non-melanoma skin cancer.
CONTACT Nancy Fusco, RN 216-844-1661
TITLE GOG 9916: A Phase I Trial of Intravenous Paclitaxel Intraperitoneal Carboplatin and Intraperitoneal Paclitaxel or Intravenous Docetaxel, Intraperitoneal Carboplatin and Intraperitoneal Paclitaxel in Patients with Previously Untreated Epithelial Ovarian Carcinoma, Fallopian Tube or Primary Peritoneal Carcinoma
DESCRIPTION This study will identify the maximum tolerated dose during the first cycle of treatment and the feasibility of either IV paclitaxel or docetaxel and intraperitoneal carboplatin on day 1 followed by intraperitoneal paclitaxel on day 8. Cycles are repeated every 3 weeks.
ELIGIBILITY
  1. Patients must have diagnosis of primary peritoneal, fallopian tube or ovarian carcinoma, Stage III or IV with either optimal (< 1 cm residual disease) or suboptimal residual disease following initial surgery. Patients must be entered on study no more than 12 weeks post operatively. Patients with carcinosarcoma are eligible.
  2. Must not have received prior radiotherapy or chemotherapy.
  3. Must have adequate bone marrow, kidney and liver function.
  4. Must have a GOG performance status 0-2.
  5. Patients must not have a severe infection, active bleeding or acute hepatitis.
  6. Patients must not have unstable angina or have had a myocardial infarction in the past 6 months. Patients with evidence of cardiac conduction abnormalities are eligible if their cardiac status has been stable for 6 months.
  7. Patients with synchronous primary endometrial cancer, or past history of endometrial cancer are not eligible unless 1) the stage is not greater than IB, 2) the cancer has less than a 3 mm invasion without vascular or lymphatic invasion, or 3) the cancer is not of a poorly differentiated subtype.
  8. Must not have had a history of other invasive malignancies within the last 5 years with the exception of non-melanoma skin cancer and localized breast cancer. 
  9. Patients must not have a history of an allergic reaction to polysorbate 80.
CONTACT Nancy Fusco, RN 216-844-1661
TITLE GOG 0129N: A Phase II Evaluation of Weekly Docetaxel in the Treatment of Recurrent or Persistent Endometrial Carcinoma
DESCRIPTION This study will estimate the anti-tumor activity of weekly docetaxel in patients with persistent or recurrent endometrial carcinoma who have failed treatment on higher priority studies. Docetaxel will be given on days 1, 8 and 15 of a 28 day cycle.
ELIGIBILITY
  1. Patients must have recurrent or persistent endometrial carcinoma which is refractory to curative therapy or established treatments. Must have had one prior chemotherapy regimen.
  2. Must have measurable disease.
  3. Must have a GOG performance status of 0-2.
  4. Patients must have adequate bone marrow, kidney, liver, and neurologic function.
  5. Must have recovered from effects of recent surgery, radiotherapy or chemotherapy.
  6. Patients must not have an active infection requiring antibiotics.
  7. Must not have had a history of other invasive malignancies within the last 5 years with the exception of non-melanoma skin cancer.
CONTACT Nancy Fusco, RN 216-844-1661
TITLE GOG 9912: A Phase I Study of Whole Pelvic Radiation Therapy with Concomitant Cisplatin and Gemcitabine Chemotherapy in Patients with Cervical Carcinoma (Stages I-IV) Limited to the Pelvis
DESCRIPTION This study will determine the toxicity of pelvic radiation therapy plus weekly cisplatin and gemcitabine chemotherapy. Patients will receive combination weekly cisplatin and gemcitabine chemotherapy as a radiosensitizer in combination with whole pelvic external beam and intracavitary radiation therapy.
ELIGIBILITY
  1. Patients must have primary, previously untreated histologically confirmed invasive carcinoma of the uterine cervix. Clinical stages IB2, IIA, IIB, IIIA, IIIB and IVA with negative para-aortic lymph nodes or biopsy negative para-aortic nodes if CT scan is suspicious for adenopathy. Must be entered within 8 weeks of diagnosis
  2. Must have adequate bone marrow, kidney and liver function. 
  3. Patients must not have renal abnormalities such as pelvic kidney, horseshoe kidney or renal transplantation which would require modification of the radiation fields.
  4. Must have a GOG performance status of 0-2.
  5. Patients must not have a severe infection.
  6. Must not have had a history of other invasive malignancies within the last 5 years with the exception of non-melanoma skin cancer.
CONTACT Nancy Fusco, RN 216-844-1661
TITLE GOG 0209: Randomized Phase III Trial of Doxorubicin/Cisplatin/Paclitaxel and G-CSF versus Carboplatin/Paclitaxel in Patients with Stage III and IV or Recurrent Endometrial Cancer
DESCRIPTION This study will determine if the combination of carboplatin and paclitaxel chemotherapy is therapeutically equivalent to the combination of doxorubicin, cisplatin and paclitaxel chemotherapy with regards to survival. Patients are randomized to receive either doxorubicin, cisplatin, paclitaxel and G-CSF or carboplatin and paclitaxel. Cycles are repeated every 21 days.
ELIGIBILITY
  1. Patients must have primary Stage III or IV or recurrent endometrial carcinoma whose potential for cure by radiation therapy or surgery alone or in combination is very poor. May not have received prior chemotherapy. At least 4 weeks should have elapsed since completion of radiation therapy.
  2. Must have measurable disease.
  3. Must have adequate bone marrow, liver and heart function.
  4. Must have a GOG performance status 0-2.
  5. Must not have a concomitant malignancy with the exception of non-melanoma skin cancer. Patients with a prior malignancy who have been disease free for < 5 years or who received prior chemotherapy for that malignancy are not eligible.
  6. Patients must not have a concomitant medical illness such as serious uncontrolled infection, uncontrolled angina or serious peripheral neuropathy. Patients with a third degree or complete heart block are not eligible unless a pacemaker is in place.
  7. Must not be sensitive to E. Coli-derived drug preparations.
CONTACT Nancy Fusco, RN 216-844-1661
TITLE GOG 0146O: A Phase II Evaluation of Irofulven in the Treatment of Recurrent or Persistent Platinum-Sensitive Ovarian or Primary Peritoneal Cancer
DESCRIPTION This study will estimate the antitumor activity of Irofulven in patients with persistent or recurrent platinum-sensitive ovarian or primary peritoneal cancer. Irofulven will be given on day 1 and 8 of each 21 day cycle.
ELIGIBILITY
  1. Patients must have recurrent or persistent ovarian or primary peritoneal carcinomas. Must have had one prior platinum-based chemotherapy regimen containing carboplatin, cisplatin or other organoplatinum compound. Must be considered platinum-sensitive according to standard GOG criteria.
  2. Must have measurable disease.
  3. Patients who have received one prior therapy regimen must have a GOG performance status of 0-2. Patients who have received two prior therapy regimens must have a GOG performance status 0-1.
  4. Must have recovered from the effects of recent surgery, radiotherapy or chemotherapy.
  5. Must be free of active infection requiring antibiotics.
  6. Patients must have adequate bone marrow, kidney, liver and neurologic function.
  7. Must not have received a prior bone marrow or stem cell transplant.
  8. Must not have a history of retinopathy and/or macular degeneration.
  9. Patients must not have a history of congestive heart failure requiring medication or uncontrolled hypertension within the past 6 months.
  10. Patients with a history of other invasive malignancies with the exception of non-melanoma skin cancer, are excluded if there is any evidence of other malignancy being present within the last 5 years.
CONTACT Nancy Fusco, RN 216-844-1661
TITLE GOG 0204: A Randomized Phase III Trial of Paclitaxel plus Cisplatin versus Vinorelbine plus Cisplatin versus Gemcitabine plus Cisplatin versus Topotecan plus Cisplatin in Stage IVB, Recurrent or Persistent Carcinoma of the Cervix
DESCRIPTION This study will determine if cisplatin plus vinorelbine, cisplatin plus gemcitabine, or cisplatin plus topotecan improves survival compared to cisplatin plus paclitaxel in stage IVB, recurrent or persistent carcinoma of the cervix. Patients will be randomized to one for four regimens: 1) paclitaxel and cisplatin, 2) vinorelbine and cisplatin, 3) gemcitabine and cisplatin and 4) topotecan and cisplatin. Cycles are repeated every 3 weeks for a maximum of six cycles.
ELIGIBILITY
  1. Patients must have histologically proven stage IVB, recurrent or persistent carcinoma of the cervix which is not amenable to curative treatment with surgery and/or radiation therapy.
  2. Must have measurabl disease.
  3. Must have adequate bone marrow, kidney and liver function.
  4. Must have a GOG performance status 0-1.
  5. Patients must have recovered from the effects of surgery, radiation therapy or chemoradiotherapy. At least 6 weeks must have elapsed from the last administration of chemoradiotherapy and at least 3 weeks must have elapsed from the administration of radiation therapy alone.
  6. Must be free of clinically significant infection.
  7. Patients with bilateral hydronephrosis which cannot be alleviated by ureteral stents or percutaneous drainage are not eligible.
  8. Patients may not have received prior treatment with chemotherapy alone.
  9. Must not have craniospinal metastases.
  10. Patients with a history of other invasive malignancies with the exception of non-melanoma skin cancer, are excluded if there is any evidence of other malignancy being present within the last 5 years.
CONTACT Nancy Fusco, RN 216-844-1661
TITLE GOG-0199: Prospective Study of Risk-Reducing Salpingo-Oophorectomy (RRSO) and Longitudinal CA-125 Screening Among Women at Increased Genetic Risk of Ovarian Cancer
DESCRIPTION This study will determine the prospective incidence of ovarian cancer, fallopian tube cancer, breast cancer, primary peritoneal carcinoma, and all cancer among women at increased risk of ovarian cancer, which a special emphasis on women who are known BRCA1/2 mutation carriers. This study will be broken down into two groups. Group 1 is made up of women undergoing ovarian cancer screening. Group 2 is made up of women undergoing risk-reducing surgery. 
ELIGIBILITY To be considered “at increased genetic risk of ovarian cancer”, subjects must have the following:
  1. Age greater than or equal to 30
  2. No prior history of ovarian cancer, including low malignant potential cancers (LMP, or primary papillary serous carcinoma of the peritoneum.
  3. Ovary status: To be eligible for the RRSO arm of this study, subjects must have at least one intact ovary, to be eligible for the screening arm of this study which targets primary ovarian cancer as the endpoint, subjects must have at least one intact ovary; to be eligible for the screening arm of this study which targets primary peritoneal cancer as the endpoint, both ovaries and fallopian tubes must have been removed. This option is available only to women who have undergone removal of their ovary/ovaries while actively participating in GOG-0199.
  4. Subjects must have satisfied at least 1 of the following additional criteria:
    a. The family of the subject has a documented deleterious BRCA1 or BRCA2 mutation – either: (1) the subject herself has tested positive for a BRCA1 or BRCA2 mutation or (2) the subject has a first-or second-degree relative with a BRCA1 or BRCA2 mutation; or 
    b. the family contains at least two ovarian or breast cancers among the subject or first or second degree relatives of the subject within the same lineage. This condition is satisfied by multiple primary cancers in the same person. Where breast cancer is required to meet this criterion, at lest one breast cancer must be pre-menopausal (age at diagnosis less than or equal to 50 if age at menopause is unknown); or 
    c. the subject is of Ashkenazi Jewish ethnicity with one first degree or two second degree relatives with breast or ovarian cancer or subject is of Ashkenazi ancestry and has had breast cancer. 
  5. Subjects with first or second degree relative has a deleterious BRCA1/2 mutation, and the subject has tested NEGATIVE for the exact same mutation, are ineligible. 
  6. Subjects who are currently pregnant or planning pregnancy during the study are ineligible.
  7. Subjects who are participating in another ovarian cancer early detection trial.
  8. Subjects with current untreated malignancy.
  9. Subjects with adjuvant radiation therapy or chemotherapy within the past 3 months.
  10. Subjects who have been treated for prior metastatic malignant disease within the past 5 years.
  11. Subjects who have undergone intraperitoneal surgery within the prior 3 months. 
  12. Subjects who have had both ovaries removed prior to study entry
CONTACT Nancy Fusco, RN 216-844-1661
TITLE RTOG C-0116: A Two-Part Phase I/II Study of Extended Field External Irradiation and Intracavity Brachytherapy Combined with Chemotherapy (weekly cisplatin) and Amifostine (weekly cisplatin and amifostine) in Carcinoma of the Cervix with Positive Para-Aortic or High Common Iliac Lymph Nodes
DESCRIPTION This study will determine the feasibility and tolerance of extended-field external radiotherapy to the pelvis and para-aortic region and intracavitary irradiation combined with weekly chemotherapy with or without amifostine. Patients will be randomized to 1 of 2 arms. Patients in arm 1 will receive extended field external radiation to the para-aortic region and pelvis, intracavitary irradiation with concurrent weekly cisplatin. Patients in arm 2 will receive extended field external radiation to the para-aortic region and pelvis, intracavitary irradiation with concurrent weekly cisplatin and amifostine.
ELIGIBILITY
  1. Patients must have carcinoma of the uterine cervix with evidence for positive 
    para-aortic or high common iliac lymph nodes.
  2. Patients will squamous cell, adenocarcinoma, and adenosquamous carcinoma are 
    eligible.
  3. Patients must have no evidence of metastatic disease outside of the pelvis (except to the para-aortic nodes).
  4. Patients must have adequate bone marrow, hepatic and renal function.
  5. Patients must no have received prior systemic chemotherapy; no pelvic radiation therapy is permitted other than transvaginal irradiation to control bleeding.
CONTACT Beverly McGloin 216-844-2528
 
TITLE GOG 175 A Randomized Phase III Trial of IV Carboplatin (AUC 6) and Paclitaxel 175 mg/m2 Every 21 Days X 3 Courses Plus Low Dose Paclitaxel 40 mg/m2/wk versus IV Carboplatin (AUC 6) and Paclitaxel 175 mg/m2 Every 21 Days X 3 Courses and Observation in Patients with Early Stage Ovarian Cancer
DESCRIPTION This study will compare the progression-free interval and overall survival in two treatment arms and will assess the frequency and severity of side effects due to the continued low dose paclitaxel regimen. Patients are randomized to either paclitaxel, carboplatin every 21 days X 3 cycles followed 4 weeks later by paclitaxel every week for 24 weeks OR paclitaxel and carboplatin every 21 days X 3 cycles followed by observation.
ELIGIBILITY

 

  1. Histologic diagnosis of ovarian cancer which is a completely resected stage II, IC or IA or IB
  2. No prior treatment except surgery
  3. Adequate bone marrow, renal and liver function
  4. GOG performance status 0-3
  5. Must not have any major systemic illness expected to affect survival
  6. Must be entered within 6 weeks of staging surgery
CONTACT Nancy Fusco, RN 216-844-1661
 
TITLE

GOG 9703: A Phase I Study of Paclitaxel, Carboplatin and Increasing Doses of Doxil in Untreated Ovarian, Peritoneal and Tubal Carcinoma

DESCRIPTION This study will determine the maximum tolerated dose of doxil when added to a standard regimen of paclitaxel and carboplatin, determine the side effects of this treatment regimen and evaluate measurable disease. Patients receive doxil followed by paclitaxel and carboplatin. Treatment is given every 28 days X 6.
ELIGIBILITY

 

  1. Untreated patients with a histologic diagnosis of ovarian , peritoneal or tubal carcinoma
  2. Adequate bone marrow, renal, heart and liver function
  3. GOG performance status 0-2
  4. No active infection or serious concurrent medical disease
CONTACT Nancy Fusco, RN 216-844-1661
 
TITLE

GOG 174: A Randomized Phase III Trial of Weekly Parenteral Methotrexate versus "Pulsed" Dactinomycin as Primary Management for Low Risk Gestational Trophoblastic Neoplasia

DESCRIPTION This study will determine whether weekly parenteral methotrexate or "pulsed" dactinomycin every 2 weeks is the more effective treatment.
ELIGIBILITY

 

  1. Untreated histologically confirmed low risk gestational trophoblastic neoplasia
  2. WHO score 0 to 4
  3. Adequate bone marrow, renal and liver function
  4. GOG performance 0-2
  5. No prior chemotherapy
  6. No evidence of metastatic disease
CONTACT Nancy Fusco, RN 216-844-1661
 
TITLE GOG 9908: Phase I Toxicity Trial of Doxorubicin-Cisplatin followed by Whole Abdominal Irradiation for Advanced Endometrial Carcinoma
DESCRIPTION This study will determine the feasibility and toxicity of doxorubicin-cisplatin chemotherapy followed by whole abdominal irradiation. Patients will receive doxorubicin and cisplatin every 3 weeks for 3 courses followed by whole abdominal irradiation.
ELIGIBILITY
  1. Stage III or IV endometrial cancer
  2. Must have had a hysterectomy and bilateral salpingo-oophorectomy and be enrolled within 8 weeks of surgery. Tumor must be maximally cytoreduced to 2 cm or less
  3. Performance status 0-2
  4. Adequate hematologic, heart, liver and kidney function
  5. No prior chemotherapy, pelvic or abdominal radiation therapy
  6. Must not have metastatic disease involving the lung or liver parenchyma, or positive inguinal or supraclavicular lymph nodes, malignant pleural effusion, or any other evidence of metastases outside the abdominopelvic area
CONTACT

Nancy Fusco, RN 216-844-1661

 
TITLE GOG 0187: Phase II Study of Paclitaxel for Ovarian Stromal Tumors as Second-Line Therapy
DESCRIPTION This study will estimate the probability of clinical response and toxicity or paclitaxel as first-line or second-line chemotherapy in measurable disease patients with malignant tumors of the ovarian stroma.  Patients will receive paclitaxel by 3-hour infusion every 21 days until disease progression.
ELIGIBILITY

 

Diagnosed with histologically confirmed ovarian stromal tumor [granulosa cell tumor, granulosa cell-theca cell tumor, Sertoli-Leydig cell tumor (androblastoma), steroid (lipid) cell tumor, gynandroblastoma, unclassified sex cord stromal tumor, sex cord tumor with annular tubules].

Patients may have either previously untreated disease, which was diagnosed within eight weeks prior to entry on study, or recurrent stromal tumor having received no more than one prior chemotherapy regimen.

3. Patients must have a GOG performance grade of 0, 1, or 2.

 

CONTACT Nancy Fusco, RN 216-844-1661
 

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