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Newark, New Jersey 07101


This purpose of this study is to compare the effects (good and bad) of chemotherapy (docetaxel) plus ZD1839 (Iressa, gefitinib) with docetaxel and placebo on the head and neck cancer to see which is better. No study has yet compared ZD1839 (Iressa, gefitinib) and docetaxel in head and neck cancer. It is possible that the addition of ZD1839 (Iressa, gefitinib) to docetaxel in head and neck cancers. It is possible that the addition of ZD1839 (Iressa, gefitinib) to docetaxel will be more effective than docetaxel alone. "ZD1839 (Iressa, gefitinib) is a new investigational drug treatment that has been shown to slow or stop growth in tumors. In clinical trials, ZD1839 (Iressa, gefitinib) has been able to shrink head and neck cancer tumors but in a small percentage of patients. A clinical trial that compared ZD1839 (Iressa, gefitinib) with methotrexate, a standard chemotherapy in head and neck cancer, showed that ZD1839 (Iressa, gefitinib) was not better than methotrexate. However, it is possible that adding ZD1839 (Iressa, gefitinib) to chemotherapy drugs will benefit patients with head and neck cancer. ZD1839 (Iressa, gefitinib) works differently from the way chemotherapy drugs work. Chemotherapy usually targets the cell's DNA and may affect both normal and cancer cells. ZD1839 (Iressa, gefitinib) targets a protein that is on the outside of cancer cells. The protein helps cancer cells to spread and grow. ZD1839 (Iressa, gefitinib) attaches to this protein and "switches it off" so that the cancer cells stop growing."


DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed squamous cell carcinoma of the head and neck - Metastatic or locally recurrent disease - No histologic type WHO 2 or 3 nasopharyngeal carcinoma - Incurable by local therapies - Meets 1 of the following criteria: - ECOG 2 AND no prior chemotherapy for metastatic or locally recurrent head and neck cancer - ECOG 0-2 AND received prior chemotherapy (i.e., ≥ 1 prior chemotherapy regimen [without docetaxel]) for metastatic or locally recurrent disease OR received prior chemotherapy (without docetaxel) as part of a primary curative therapy within the past 6 months - Measurable or non-measurable disease - Disease within a previously irradiated field is considered measurable provided there is unequivocal disease progression or biopsy-proven residual carcinoma after radiotherapy - Persistent disease after radiotherapy must be biopsy-proven ≥ 8 weeks after completion of radiotherapy - No tumors that are unequivocally invading major vessels (e.g. carotid artery) - No tumor-related hemorrhagic events in the past 3 months that require major medical intervention (e.g., surgery or embolization) - No known brain metastasis PATIENT CHARACTERISTICS: Age - 18 and over Performance status - See Disease Characteristics Life expectancy - Not specified Hematopoietic - Absolute neutrophil count ≥ 1,500/mm^3 - Platelet count ≥ 100,000/mm^3 - Hemoglobin ≥ 8.0 g/dL Hepatic - Alkaline phosphatase AND AST or ALT meeting criteria for 1 of the following: - Alkaline phosphatase normal AND AST or ALT ≤ 5 times upper limit of normal (ULN) - Alkaline phosphatase ≤ 2.5 times UNL AND AST or ALT ≤ 1.5 times ULN - Alkaline phosphatase ≤ 5 times ULN and AST or ALT normal - Bilirubin normal - Renal - Creatinine < 2.0 mg/dL OR - Creatinine clearance > 60 mL/min Cardiovascular - No uncontrolled hypertension - No unstable angina - No congestive heart failure - No serious arrhythmia requiring medication Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for 3 months after study participation - No hypercalcemia related to head and neck cancer - No peripheral neuropathy ≥ grade 2 - No hypersensitivity to gefitinib or any of its excipients - No severe hypersensitivity to docetaxel or other drugs formulated with polysorbate 80 - No unstable systemic disease - No active infection - No significant traumatic injury within the past 3 weeks - No other malignancy within the past 5 years except curatively treated squamous cell or basal cell skin cancer or carcinoma in situ of the cervix - No other co-existing condition that would preclude study compliance PRIOR CONCURRENT THERAPY: Biologic therapy - No prior monoclonal antibody ABX-EBX or monoclonal antibody MDX-447 - No prior cetuximab - At least 2 weeks since prior biologic/targeted therapy - No concurrent immunotherapy - No concurrent colony-stimulating factors (e.g., filgrastim [G-CSF] or sargramostim [GM-CSF]) Chemotherapy - See Disease Characteristics - Prior paclitaxel allowed provided there was no disease progression during treatment - At least 4 weeks since prior chemotherapy and recovered - No prior docetaxel - No other concurrent chemotherapy Endocrine therapy - No concurrent antitumor hormonal therapy - Concurrent contraceptives, replacement steroids, and dexamethasone allowed Radiotherapy - See Disease Characteristics - At least 3 weeks since prior radiotherapy and recovered - No concurrent radiotherapy Surgery - At least 3 weeks since prior major surgery and recovered Other - See Disease Characteristics - No other prior systemic epidermal growth factor receptor inhibitors, including any of the following: - Gefitinib - Erlotinib - PKI166 - CI-1033 - EKB-569 - No concurrent CYP3A4 inducers, including any of the following: - Phenytoin - Carbamazepine - Rifampin - Phenobarbital - Hypericum perforatum (St. John's wort) - No concurrent combination antiretroviral therapy for HIV-positive patients - No concurrent proton pump inhibitors or H2 antagonists within 4 hours after gefitinib administration - No concurrent therapeutic anticoagulation - No other concurrent antitumor therapy - No other concurrent experimental medications



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Newark, New Jersey 07101
United States

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Site Status: N/A

Data Source: ClinicalTrials.gov

Date Processed: March 16, 2018

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