Gefitinib and Docetaxel in Treating Patients With Advanced Solid Tumors

Study Overview
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Brief Summary
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RATIONALE: Gefitinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Drugs used in chemotherapy such as docetaxel work in different ways to stop tumor cells from dividing so they stop growing or die. Giving gefitinib with docetaxel may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of gefitinib when given with docetaxel in treating patients with advanced solid tumors.

Detailed Description
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OBJECTIVES: Determine the maximum tolerated dose of gefitinib when administered with docetaxel in patients with advanced solid tumors. Determine the safety and efficacy of this regimen in these patients. Determine the pharmacokinetics of this regimen in these patients. OUTLINE: This is a dose-escalation study of gefitinib. Patients receive oral gefitinib once daily on days 1 and 2 and docetaxel IV over 1 hour on day 3. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of gefitinib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Patients are followed for survival. PROJECTED ACCRUAL: A total of 3-42 patients will be accrued for this study.

Official Title
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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

Conditions
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Unspecified Adult Solid Tumor, Protocol Specific

Intervention / Treatment
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* Drug: docetaxel
* Drug: gefitinib


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: docetaxel|nan|
|Drug: gefitinib|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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unspecified adult solid tumor, protocol specific