Phase III Randomized, Placebo Controlled, Trial Of Docetaxel Versus Docetaxel Plus ZD1839 (Iressa, Gefitinib, NSC 715055) In Performance Status 2 Or Previously Treated Patients With Recurrent Or Metastatic Head And Neck Cancer
Inclusion Criteria
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