Imatinib Mesylate and Chemotherapy in Treating Patients With Extensive-Stage Small Cell Lung Cancer

NCT00045604 | Completed Phase 1

• 3 other identifiers: CDR0000256923MSKCC-02015NCI-5653
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining imatinib mesylate with chemotherapy may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of combining imatinib mesylate with irinotecan and cisplatin in treating patients who have extensive-stage small cell lung cancer

Conditions

Lung Cancer

Keywords

extensive stage small cell lung cancer

Interventions

cisplatin DRUG

imatinib mesylate DRUG

irinotecan hydrochloride DRUG

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically confirmed small cell lung cancer * Extensive stage disease * Measurable or evaluable indicator lesion * No symptomatic or uncontrolled brain or leptomeningeal involvement PATIENT CHARACTERISTICS: Age * 18 and over Performance status * Karnofsky 70-100% Life expectancy * Not specified Hematopoietic * WBC at least 4,000/mm3 * Platelet count at least 160,000/mm3 * Hemoglobin at least 10 g/dL Hepatic * Bilirubin no greater than 1 mg/dL * AST no greater than 2.5 times upper limit of normal (ULN) * Alkaline phosphatase no greater than 5 times ULN Renal * Creatinine less than 1.5 mg/dL OR * Creatinine clearance at least 50 mL/min Cardiovascular * No symptomatic congestive heart failure * No unstable angina pectoris * No uncontrolled cardiac arrhythmia Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective barrier contraception during and for 3 months after study * No other active cancer except previously treated carcinoma in situ, non -melanoma skin cancer, or stage I prostate cancer * No ongoing or active infection * No psychiatric illness or social situation that would preclude study * No other concurrent uncontrolled illness PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * No prior chemotherapy except for non-cancer conditions (e.g., low-dose methotrexate for rheumatoid arthritis) Endocrine therapy * Not specified Radiotherapy * At least 2 weeks since prior radiotherapy to major bone marrow-containing areas Surgery * Not specified Other * No concurrent warfarin for therapeutic anticoagulation * Low-molecular weight heparin or heparin allowed

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

Conditions

Lung Neoplasms

Interventions

Cisplatin; Imatinib Mesylate; Irinotecan

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines; Camptothecin; Alkaloids

Study Officials

• Lee M. Krug, MD

  Memorial Sloan Kettering Cancer Center

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: September 6, 2002
• First Posted: January 27, 2003
• Study Start: July 1, 2002
• Last Updated: July 24, 2008

Record last verified: 2004-04

Locations

US (1)