Gefitinib and Docetaxel in Treating Patients With Advanced Solid Tumors

NCT00084786 | Completed Phase 1

• 2 other identifiers: 04-003MSKCC-04003
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

Interventions

docetaxel DRUG

gefitinib DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

MeSH Terms

Interventions

Docetaxel; Gefitinib

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Naiyer Rizvi, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

• David B. Solit, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 10, 2004
• First Posted: June 11, 2004
• Study Start: March 1, 2004
• Primary Completion: July 1, 2006
• Last Updated: January 17, 2013

Record last verified: 2013-01

Locations

US (1)