Status:
COMPLETED
Gefitinib and Docetaxel in Treating Patients With Advanced Solid Tumors
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Unspecified Adult Solid Tumor, Protocol Specific
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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...
Detailed Description
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 p...
Eligibility Criteria
Inclusion
- 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)
Exclusion
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00084786
Start Date
March 1 2004
Last Update
January 17 2013
Active Locations (1)
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1
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021