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

Fecha de inicio: 1 de agosto de 2004

Inclusion Criteria: * Histologically or cytologically confirmed squamous cell carcinoma of the head and neck; patient must not have nasopharyngeal carcinoma of histologic types World Health Organization (WHO) 2 and 3 * Metastatic or locally recurrent carcinoma of the head and neck that is considered incurable by local therapies * Any number of prior chemotherapy or biologic/targeted therapy regimens is allowed * No prior systemic EGFR inhibitors, such as ZD1839 (Iressa, gefitinib)/Iressa (AstraZeneca), ABX-EBX (Abgenix), MDX-447 (Medarex/Merck), OSI-774/Tarceva (OSI pharmaceuticals), C225/Cetuximab (ImClone), PKI166 (Novartis), CI-1033 (Parke-Davis), EKB-569 (Wyeth Ayerst); treatment with paclitaxel is allowed if the patient did not progress while on paclitaxel * NOTE: the use of cetuximab given concurrently with radiation or chemoradiotherapy for up to 9 total weekly doses, as part of initial potentially curative therapy is allowed, if completed \> 6 months prior to registration * Patients must not receiving any other investigational agent while on the study * Patients must have either: * Strata A: * Eastern Cooperative Oncology Group (ECOG) performance status (PS) 2 (in bed 50% of the time. Ambulatory and capable of all self-care, but unable to carry out any work activities; up and about more than 50% of waking hours), AND no prior chemotherapy for recurrent metastatic head and neck cancer OR * Strata B * PS 0-2 AND prior chemotherapy (i.e. one or more prior chemotherapy regimens (without docetaxel)) for locally recurrent/metastatic disease or exposure to prior chemotherapy (without docetaxel) as part of primary curative therapy \< 6 months prior to randomization; patients who receive chemotherapy as part of potentially curative therapy of primary disease within 6 months of randomization will be considered as having prior chemotherapy for recurrent/metastatic disease, whereas patients who received chemotherapy as part of potentially curative therapy of disease \> 6 months of randomization will be considered as having no prior chemotherapy for recurrent/metastatic disease * Patients must have fully recovered from the effects of any prior surgery, chemotherapy, or radiation therapy * A minimum time period of 3 weeks must elapse between the completion of radiation therapy and randomization to the study * A minimum period of 4 weeks must elapse between the last administration of any prior chemotherapy and randomization to the study * At least 2 weeks must elapse between the last administration of biologic/targeted therapy and randomization to the study * Patients must be \> 3 weeks since major surgery, or significant traumatic injury prior to randomization * Absolute neutrophil count (ANC) \>= 1500 /mm\^3 * Platelets \>= 100,000 /mm\^3 * Hemoglobin \>= 8.0 g/dl * Bilirubin within normal limits * Creatinine \< 2.0 or creatinine clearance of \> 60 ml/min * All females of childbearing potential must have a blood test or urine study within 2 weeks prior to randomization to rule out pregnancy * Women of childbearing potential and sexually active males must use an accepted and effective method of contraception while on treatment and for three months after the completion of treatment * Patients must have measurable or non-measurable disease based on Response Evaluation Criteria In Solid Tumors (RECIST); baseline measurements and evaluations must be obtained \< 4 weeks of randomization; all areas of disease should be recorded and mapped out in order to assess response and uniformity of response to therapy; disease in previously irradiated sites is considered measurable if there has been unequivocal disease progression or biopsy-proven residual carcinoma following radiation therapy; persistent disease after radiotherapy must be biopsy proven at least 8 weeks after completion of radiation therapy * Radiographic findings are acceptable providing that clear-cut measurements can be made * Patients with a prior history of squamous cell or basal carcinoma of the skin or in situ cervical cancer must have been curatively treated. Patients with a history of other prior malignancy must have been treated with curative intent and must have remained disease-free for 5 years post diagnosis * Drugs that are Cytochrome P450 3A4 (CYP3A4) inhibitors should be generally avoided and if possible, discontinued, 1 week prior to initiating study drug; however, if medically necessary, they can be taken with caution after consulting with the study chair * From patients consenting to participate in the correlative studies: * Tissues must be submitted as outlined in Section 10; if tissue cannot be submitted, written justification must be submitted to the ECOG Pathology Coordinating Office Exclusion criteria: * Prior therapy with docetaxel at any time (even if part of prior curative treatment) * Unstable systemic disease, including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, or serious arrhythmia requiring medication * Hypercalcemia related to head and neck cancer * Brain metastasis * Current peripheral neuropathy \>= grade 2 at time of randomization * Patients have co-existing condition that would preclude full compliance with the study * Known hypersensitivity to ZD1839 (Iressa, gefitinib) or any excipients of this product; prior history of severe hypersensitivity reaction to Docetaxel or other drugs formulated with polysorbate 80 * HIV positive patient's receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with ZD1839 (Iressa, gefitinib) * Patients have had tumor-related hemorrhagic events in the previous three months that required as major medical intervention, such as surgery or embolization * Patients are on therapeutic anticoagulation or have tumors that are unequivocally invading major vessels (e.g. carotid artery) * Females are pregnant or breast feeding because chemotherapy may be harmful to the fetus or the nursing infant; also, the effects of ZD1839 (Iressa, gefitinib) on the developing human fetus are unknown