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Head & Neck Trials
TITLE E 1302: Phase III Randomized, Placebo-Controlled, Trial of Docetaxel versus Docetaxel plus ZD1839 (Iressa, Gefitinib) in Performance Status 2 or Previously Treated Patients with Recurrent or Metastatic Head and Neck Cancer
DESCRIPTION This study will compare the effects of treatment with chemotherapy (docetaxel) plus a drug known as ZD1839 (Iressa, gefitinib) to the effects of treatment with docetaxel and placebo in the head and neck cancer to see which is better. Patients first treated with docetaxel plus placebo may also be given ZD1839 alone but only at the time the cancer start growing again. The study will also look at whether using ZD1839 will be effective in treating this type of cancer. Patients will be placed into one of two groups by chance. Group 1 (Arm A) will be given a drug called docetaxel and a placebo. Group 2 (Arm B) will be given a drug called docetaxel and the drug ZD1839. Patients in treatment Arm A will be given docetaxel on three days of a 28-day cycle. Cycles will be repeated every 28 days. Placebo will also be given as a pill each day. Patients in treatment Arm B will also be given docetaxel on three days of a 28-day cycle. Cycles will be repeated every 28 days. Patients on Arm B will also be given one ZD1839 pill each day until the disease progresses (but no placebo). Patients on Arm A whose disease gets worse will have the option to enroll on Arm C and receive ZD1839. 
ELIGIBILITY
  1. Patients must have confirmed squamous cell carcinoma of the head and neck. Must not have nasopharyngeal carcinoma of histologic types WHO 2 and 3. Disease must be metastatic or locally recurrent and be considered incurable by local therapies
  2. Must have fully recovered from the side effects of any prior surgery, chemotherapy, or radiation therapy. Any number of prior chemotherapy or biologic/targeted therapy regimens is allowed. 
  3. Must have no known brain metastases and no hypercalcemia related to the head or neck cancer
  4. Must have adequate bone marrow, liver and kidney function
  5. Cannot have received prior therapy with docetaxel at any time (even if part of prior curative treatment), or prior systemic EGFR inhibitors such as Iressa, gefitinib)/Iressa, ABX-EBX, MDX-447, OSI-774/Tarceva, C225/Cetuximab, PKI166, CI-1033, or EKB-569. Treatment with Paclitaxel is allowed if the patient did not progress while on the drug 
  6. Cannot have had unstable systemic disease, including active infection, uncontrolled hypertension, unstable angina, congestive heart failure or serious arrhythmia requiring medication 
  7. Must be 18 years of age or older
CONTACT Sue Bergant, RN 216- 844-7012 
TITLE CASE 6304: A Phase II Study of Bevacizumab in Combination with Docetaxel and Radiation in Locally Advanced Squamous Cell Cancer of the Head and Neck.
DESCRIPTION This study will evaluate how patients with advanced squamous cell cancer of the head and neck respond to treatment with a combination of radiation and the drugs Docetaxel and bevacizumab. Bevacizumab will be given intravenously (by IV or by needle in the arm) every two weeks during radiation, and up to one year after radiation therapy is finished. Docetaxel (a standard chemotherapy drug) will be given intravenously once per week only during the course of radiation. Radiation will be given daily, five days a week (Monday through Friday), for about 8 weeks. Chemotherapy will be administered on an outpatient basis. Neck surgery is recommended 8 weeks after chemotherapy is completed.
ELIGIBILITY
  1. Must have confirmed locally advanced (stage III or IV) squamous cell carcinoma of the head and neck without distant metastases
  2. Must have measurable disease within 4 weeks of registration
  3. Must not have received any prior chemotherapy, radiation therapy, or investigational antitumor drug
  4. Must be at least 18 years of age
  5. Must have life expectancy greater than 12 weeks
  6. Must have ECOG performance status 0-1, normal marrow, kidney and liver function, and no clinically significant heart disease
CONTACT Sue Bergant, RN 216- 844-7012 
TITLE CASE 5304: Phase II Trial of BAY 43-9006 in Patients with Advanced Anaplastic Carcinoma of the Thyroid.
DESCRIPTION This study will determine whether patients will respond by at least 20% when given the drug BAY 43-9006 (sorafenib) to treat anaplastic thyroid cancer. Patients will swallow tablets whole with 8 ounces of water, each morning and each evening, with or without food (if with food, patients must consume a moderate- to low-fat meal). 
ELIGIBILITY
  1. Patients with anaplastic thyroid cancer are eligible if their disease has progressed after treatment with cytotoxic chemotherapy (given alone or with radiation) and their disease is not considered amenable to radiation or surgery with curative intent. 
  2. Must have measurable disease
  3. May have received either no cytoxic chemotherapy or up to 2 prior systemic cytoxic chemotherapy regimens. Any combined modality systemic cytoxic chemotherapy will be considered one prior cytotoxic regimen
  4. Patients must have fully recovered from side effects following initial surgery (relapsing) or radiation + chemotherapy
  5. Must be 18 years of age or older
  6. Must have life expectancy greater than 8 weeks
  7. Must have ECOG performance status 0-2 and normal marrow, liver and kidney function
  8. Must be able to swallow pills
CONTACT Sue Bergant, RN 216-844-7012 
TITLE CWRU 3302: Phase IB/II Trial of Combined Modality Combretastatin A-4 Phosphate (CA4P)-Based Therapy for Patients with Newly Diagnosed Anaplastic Thyroid Cancer [Induction Chemotherapy with Doxorubicin/Cisplatin; Combined Modality Therapy with CA4P and Radiation; Followed by 2 Cycles of CA4P Consolidation
DESCRIPTION This study will determine the objective response rate of CA4P-based combined modality therapy given to patients with newly diagnosed anaplastic carcinoma of the thyroid. Patients will receive therapy in three phases. During the induction phase patients will receive initial combination chemotherapy for 1 cycle (3 weeks), which includes doxorubicin and cisplatin on day 1. During the combined modality phase (with dose escalation of CA4P) starting day #22 if fully recovered from cycle 1 of induction phase treatment, combined modality therapy with CA4P and concurrent radiation is given. The consolidation phase begins after a 4-6 week recovery from the combined modality phase of treatment, CA4P will be administered for two 4-week cycles on the following schedule: CA4P given on day #1, 8, 15 of a 4-week (28 day) treatment cycle times 2 cycles (2 months). Patients will continue to receive treatment through the consolidation phase unless unacceptable toxicity or disease progression is documented. After the consolidation phase, patients will be observed for progression/relapse and survival.
ELIGIBILITY
  1. Patients must have biopsy-proven, regionally advanced (i.e., disease confined to the neck and/or superior mediastinum (i.e., disease above the level of the carina)] anaplastic or poorly differentiated variant thyroid carcinoma – with measurable disease (preferable); evaluable disease (at a minimum abnormalities on physical exam or radiographic studies that may not be precisely measured but readily followed); or biopsy confirmation of anaplastic thyroid carcinoma for which the patient has undergone complete resection without measurable or evaluable disease, but for whom overall survival can be followed as the major objective of the study.
  2. No prior chemotherapy or radiation therapy is allowed. Patients will be eligible if they have undergone attempt at resection or cytoreductive surgery irrespective of surgical margins provided there is no distant metastasis.
  3. Patients, who are deemed inoperable, with bulky thyroid/neck masses and/or suspicion of airway obstruction must undergo screening indirect and direct laryngoscopy to ensure patency of the trachea/airway prior to study enrollment and treatment.
  4. Patients must be at least 18 years of age.
  5. Patients must have adequate cardiac, bone marrow, liver and kidney function.
CONTACT Sue Bergant, RN 216-844-7012 
   
TITLE ICC 2302: Phase II Trial of Combretastatin A-4 Phosphate (CA4P) in Advanced Anaplastic Carcinoma of the Thyroid
DESCRIPTION This study will determine the objective response rate of CA4P given to patients with anaplastic carcinoma of the thyroid and determine whether CA4P alters the natural history of anaplastic thyroid cancer by virtue of doubling the median survival of patients with advanced disease from 4-6 months to 12 months. Patients will receive a 10-minute infusion of CA4P on days 1, 8 and 15 of each 4-week cycle. 
ELIGIBILITY
  1. Patients must have biopsy proven anaplastic or poorly differentiated variant thyroid carcinoma with measurable or evaluable disease.
  2. Patients may not have received prior therapy for metastatic disease beyond combined modality therapy at diagnosis.
  3. Patients with bulky thyroid/neck masses and/or suspicion of airway obstruction must undergo screening indirect and direct laryngoscopy to ensure patency of the trachea/airway prior to study enrollment and treatment.
  4. Patients must have a life expectancy of greater than or equal to 12 weeks.
  5. Patients must have adequate bone marrow, hepatic and renal function.
CONTACT Sue Bergant, RN 216-844-7012 
 
TITLE CWRU 1301: A Phase I Study of the Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor, OSI-774, in Combination with Docetaxel and Radiation in Locally Advanced Squamous Cell Cancer of the Head and Neck
DESCRIPTION The purpose of this study is to determine the maximum tolerated dose of the investigational drug and docetaxel given in addition to radiation therapy. Effectiveness and side effects of the drugs combined with radiation will also be monitored.
ELIGIBILITY
  1. Histologically or cytologically confirmed local advanced (Stage III or IV) squamous cell carcinoma of the head and neck without distant metastatic disease

    Must have measurable disease
  2. 18 years of age or older
  3. ECOG performance status of 0, 1, or 2
  4. Normal organ and bone marrow function
  5. Period of 5 years has elapsed since treatment of any previous cancer except skin cancer or CIS of cervix
  6. No clinically significant heart disease
  7. Nor prior chemotherapy or radiation therapy
  8. No brain metastases
  9. Not HIV positive
CONTACT Sue Bergant, RN 216-844-7012 
 

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