Clinical Trials

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Genitourinary Trials
TITLE E 1804: Phase II Trial of Sorafenib (BAY43-9006) (IND 69896; NSC 724772) in Patients with Advanced Urothelial Cancer
DESCRIPTION This study will evaluate the 4-month progression-free survival rate, response rate and toxicity of BAY 43-9006 in patients with 
progressing regional or metastatic transitional cell carcinoma. BAY 43-9006 will be administered at a dose of 400 mg (2 tablets) orally 
twice daily (every 12 hours) (total daily dose: 800 mg)(one cycle = 8 weeks).
ELIGIBILITY
  1. Age ≥ 18 years
  2. Histologically confirmed transitional cell carcinoma or mixed histologies containing a component of transitional cell carcinoma of the urothelium with manifestations of progressing regional or metastatic cancer OR non-transitional histologies including adenocarcinoma or 
    squamous cell carcinomas representing greater than 90% of the tumor
  3. Patients must have progressed on one and only one prior systemic chemotherapy for metastatic disease.
  4. Must not have had prior biologic response modifier therapy
  5. ECOG performance status of 0 or 1.
  6. Patients must have normal bone marrow, liver and kidney function.
  7. No history of severe cardiovascular disease
  8. Must not be on therapeutic anticoagulation 
CONTACT Sue Bergant RN 216-844-7012
TITLE GLAX 1805: A Phase II Study of GW786034 Using a Randomized Discontinuation Design in Subjects with Locally Recurrent or 
Metastatic Clear-Cell Renal Cell Carcinoma (RCC)
DESCRIPTION This study will evaluate the safety and effectiveness of GW786034 in adult subjects with locally recurrent or metastatic 
clear-cell RCC. Subjects will receive oral GW786034, 800 mg once daily for 12 weeks, starting on Day 1.
ELIGIBILITY
  1. Age ≥ 21 years
  2. Histologically or cytologically confirmed diagnosis of renal cell carcinoma of predominantly clear-cell histology which is metastatic or locally recurrent.
  3. Either no prior chemotherapy or failed only 1 prior cytokine-based or bevacizumab-based therapy.
  4. ECOG Performance Status (PS) of 0 or 1.
  5. Patients must have normal bone marrow, liver and kidney function.
  6. Must not have received prior cytokine or non-bevacizumab therapies
  7. No history of hypercalcemia
  8. No history of cerebrovascular accident
  9. No brain metastases
CONTACT Sue Bergant RN 216-844-7012
TITLE E 2805: A Randomized, Double Blind Phase III Trial of Adjuvant Sunitinib versus Sorafenib versus Placebo in Patients with Resected Renal Cell  Carcinoma
DESCRIPTION This study will determine if either Sunitinib or Sorafenib can prevent recurrence of kidney cancer and compare the effects of 
the Sunitinib and the Sorafenib with placebo to see which is better. Patients will take 2 tablets of Sorafenib of placebo twice a day for 6 
weeks for approximately one year and 4 capsules of Sunitinib or placebo once a day for 4 weeks followed by a 2 week break for approximately 
one year. Patients can be registered before or after surgery.
ELIGIBILITY
  1. Age > 18 years
  2. If registered presurgery: Patients must have primary-intact renal cell carcinoma, eligible for nephrectomy with curative intent. 
  3. If registered post surgery: No evidence of residual or metastatic cancer after surgery
  4. Must be no less than 3 weeks and no more than 10 weeks from surgery at randomization
  5. Patients with no prior anti-cancer therapy are permitted in either the adjuvant or neoadjuvant setting. This includes metastectomy 
    for renal cell carcinoma, or radiation therapy to the renal bed 
  6. Patients must have histological or cytological confirmed renal cell carcinoma T1B (Fuhrman grade 3-4), T2, T3 and T4 with N0-2 and 
    must have undergone a full surgical resection (radical nephrectomy or partial nephrectomy) by either open or laparoscopic technique.
  7. ECOG performance status 0 – 2
  8. Patients must have normal bone marrow, liver and kidney function.
  9. No pre-existing thyroid abnormalities
CONTACT Sue Bergant RN 216-844-7012
TITLE SANO 1805: A Multicenter, Open-Label, Randomized, Phase III Trial Comparing Immediate Adjuvant Hormonal Therapy (ELIGARDŽ- leuprolide acetate) in 
Combination with TAXOTEREŽ (docetaxel) Administered Every Three Weeks Versus Hormonal Therapy Alone Versus Deferred Therapy Followed by the 
Same Therapeutic Options in Patients with Prostate Cancer at High Risk of Relapse After Radical Prostatectomy
DESCRIPTION This study aims to determine the long-term survival of patients. In addition, the objective of the study is also to compare if 
the combination of TaxotereŽ (a chemotherapy drug) with EligardŽ (hormonal therapy) is more efficient than and as safe as EligardŽ alone. 
Patients will receive, either around 2 months after surgery or later, 6 courses of chemotherapy with TaxotereŽ and 6 courses of hormone therapy with EligardŽ or 6 courses of EligardŽ only.
ELIGIBILITY
  1. Pathologically confirmed adenocarcinoma of the prostate based on central pathology review.
  2. Patients have undergone a radical prostatectomy.
  3. No bone or lung metastases
  4. No prior systemic treatment for prostate cancer with hormonal therapy, chemotherapy or any other anticancer treatment. No prior radiation 
  5. Serum testosterone > 150 ng/dL
  6. ECOG performance status ≤1
  7. Age ≥ 18 years
  8. Patients must have normal bone marrow, liver and kidney function.
CONTACT Sue Bergant RN 216-844-7012
TITLE ICC 1802: Cytokine Genotypes and Risk of Depression Syndromes in Patients Undergoing Radiotherapy for Prostate Cancer, and Efficacy of Treatment with Bupropion
DESCRIPTION The purpose of this study is to: 1) measure the number of men who get symptoms of depression during radiotherapy for prostate cancer, and 2) understand who is more likely to get depression symptoms during radiotherapy, and to treat the symptoms if they occur
ELIGIBILITY
  1. Age 18-75, able to informed consent
  2. Initiating radiation therapy alone, either external beam or brachytherapy, for localized carcinoma of the prostate, without associated chemotherapy
  3. No significant current neuropsychiatric diagnoses or current psychiatric treatment
  4. No current immunotherapy or immunosuppressant treatment, hematologic malignancy or other immunologic disorder
CONTACT Duare Valenzuela 216-844-5390
TITLE

S 9346:Intermediate Androgen Deprivation in Patients With Stage D2 Prostate

DESCRIPTION This study is designed around the use of combination hormone therapy with an LHRH analogue and an antiandrogen. Induction therapy consists of combined androgen deprivation for 8 cycles of treatment (7 months). Consolidation consists of a randomization to one of two treatment arms: continuous hormonal therapy or intermittent hormonal therapy. This study will assess whether patients randomized to the intermittent combined androgen therapy arm have survival that is not substantially worse than patients randomized to the continuous combined androgen therapy arm.
ELIGIBILITY

 

  1. Histologically or cytologically proven diagnosis of adenocarcinoma of the prostate.
  2. Patients who have already begun the use of combined androgen deprivation therapy with LHRH agonist and antiandrogen may be eligible for late induction registration.
  3. Registering institution must us the Hybritech or Abbott PSA assays.
  4. Must have an elevated PSA > 5 ng/ml within 56 days prior to registration.
  5. Patients with a history of prior neoadjuvant or adjuvant hormone therapy must have received four or less months of hormone treatment. Must not have received finasteride unless treatment was administered for nine months or less. All therapy must have been discontinued more than a year prior to registration.
  6. Must not have had a bilateral orchiectomy.
  7. Must not have acute cord compression.
  8. Performance status 0-2 by SWOG criteria.
CONTACT Ann Ness, RN 216-844-1637
 

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