A Phase I Dose Escalation of ZD1839 (Iressa®) (Days 1 and 2) and Docetaxel (Day 3) Every 3 Weeks in Patients With an Advanced Solid Tumor

Study start date: March 1, 2004

DISEASE CHARACTERISTICS: Histologically confirmed advanced solid tumor Failed standard treatment OR no standard treatment exists Measurable or evaluable indicator lesions No uncontrolled CNS metastases (i.e., any known CNS lesion that is progressive [e.g., ≥ 25% growth], symptomatic, and/or requires escalating doses of corticosteroids) PATIENT CHARACTERISTICS: Age 18 and over Performance status Karnofsky 70-100% Life expectancy Not specified Hematopoietic WBC ≥ 3,000/mm^3 Hemoglobin ≥ 9.0 g/dL Platelet count ≥ 100,000/mm^3 Hepatic Bilirubin ≤ 1.5 times upper limit of normal (ULN) AST ≤ 2.0 times ULN Renal Creatinine ≤ 1.5 mg/dL OR Creatinine clearance ≥ 55 mL/min Cardiovascular No congestive heart failure No recent myocardial infarction No unstable angina No uncontrolled hypertension Pulmonary No clinically active interstitial lung disease Chronic, stable, asymptomatic radiographic changes allowed Ophthalmic No corneal abnormality No history of dry eye syndrome or ocular surface diseases Other No known severe hypersensitivity to gefitinib or any of its excipients No unstable systemic disease No active infection No other significant medical history or unstable medical condition Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No sperm donation during and for 3 months after study participation PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy At least 3 weeks since prior chemotherapy No more than 2 prior chemotherapy regimens for metastatic cancer No prior docetaxel Endocrine therapy See Disease Characteristics Radiotherapy At least 3 weeks since prior radiotherapy to a major bone marrow-containing area Surgery Not specified Other No prior gefitinib or erlotinib No other prior epidermal growth factor receptor tyrosine kinase inhibitors More than 30 days since prior non-approved or other investigational drugs No concurrent administration of any of the following CYP3A4 inhibitors or inducers: Ketoconazole Itraconazole Clarithromycin Erythromycin Grapefruit juice Troleandomycin Diltiazem Verapamil Rifampin Phenytoin Carbamazepine Barbiturates Hypericum perforatum (St. John's wort) No concurrent warfarin No concurrent drugs that cause significant sustained elevations of gastric pH (pH ≥ 5)