Gefitinib and Docetaxel in Treating Patients With Advanced Solid Tumors

NCT ID: NCT00084786

Last Updated: 2013-01-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-03-31

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 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

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.

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Study Design

• Primary Study Purpose: TREATMENT

Interventions

docetaxel

Intervention Type: DRUG

gefitinib

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role: lead

Principal Investigators

Naiyer Rizvi, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

David B. Solit, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Countries

United States

Other Identifiers

MSKCC-04003

Identifier Type: -

Identifier Source: secondary_id

04-003

Identifier Type: -

Identifier Source: org_study_id