- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00084786
Gefitinib and Docetaxel in Treating Patients With Advanced Solid Tumors
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
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.
Study Overview
Status
Intervention / Treatment
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 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.
Study Type
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
New York
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New York, New York, United States, 10021
- Memorial Sloan-Kettering Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: David B. Solit, MD, Memorial Sloan Kettering Cancer Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 04-003
- MSKCC-04003
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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