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

NCT00052494 | Completed Phase 1

• 3 other identifiers: PMH-PHL-008CDR0000258487NCI-5684
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Lung Cancer

Keywords

extensive stage small cell lung cancer; recurrent small cell lung cancer

Study Arms (1)

STI-571 with cisplatin and irinotecan

EXPERIMENTAL

Drug: cisplatin; Drug: imatinib mesylate; Drug: irinotecan hydrochloride

Interventions

cisplatin DRUG

STI-571 with cisplatin and irinotecan

imatinib mesylate DRUG

STI-571 with cisplatin and irinotecan

irinotecan hydrochloride DRUG

STI-571 with cisplatin and irinotecan

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed extensive stage small cell lung cancer * Incurable but amenable to treatment with chemotherapy * c-kit positive by immunohistochemistry of original biopsy or other metastatic site * At least one unidimensionally measurable lesion * \> 20 mm by conventional techniques or \> 10 mm by spiral CT scan * No prior radiotherapy to target measurable lesion(s), unless there is documented disease progression * No known brain metastases PATIENT CHARACTERISTICS: Age * Not specified Performance status * ECOG 0-1 OR * Karnofsky 70-100% Life expectancy * More than 6 weeks Hematopoietic * WBC ≥ 3,000/mm\^3 * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 Hepatic * Bilirubin normal * AST and/or ALT ≤ 2.5 times upper limit of normal Renal * Creatinine normal OR * Creatinine clearance ≥ 60 mL/min Cardiovascular * No symptomatic congestive heart failure * No unstable angina pectoris * No cardiac arrhythmia Gastrointestinal * No concurrent untreated upper gastrointestinal bleeding that has not been fully investigated * No gastrointestinal disease that would impair drug absorption Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective barrier contraception prior to, during, and for 3 months after study participation * No history of ototoxicity * No history of peripheral neuropathy * No traumatic injury within the past 21 days * No ongoing or active infection * No other concurrent significant medical condition that would preclude study participation * No concurrent psychiatric condition or social situation that would preclude study compliance * No other malignancy within the past 5 years except treated nonmelanoma skin cancer, carcinoma in situ, or stage A prostate cancer PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * See Disease Characteristics * No prior chemotherapy * No other concurrent chemotherapy Endocrine therapy * Not specified Radiotherapy * See Disease Characteristics * More than 4 weeks since prior radiotherapy * No prior radiotherapy to more than 25% of marrow Surgery * More than 3 weeks since prior major surgery * No prior surgical procedure impairing absorption Other * No prior c-kit-targeted therapy * No concurrent therapeutic dose of warfarin * Mini-dose warfarin for prophylaxis and low-molecular weight heparin allowed * No concurrent combination antiretroviral therapy for HIV-positive patients * No other concurrent investigational agents * No concurrent amifostine * No other concurrent anticancer therapy

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

Sponsors & Collaborators

• University Health Network, Toronto: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

MeSH Terms

Conditions

Lung Neoplasms; Small Cell Lung Carcinoma

Interventions

Cisplatin; Imatinib Mesylate; Irinotecan

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

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

• Mark D. Vincent, MD

  London Health Sciences Centre

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2003
• First Posted: January 27, 2003
• Study Start: April 1, 2003
• Primary Completion: February 1, 2009
• Last Updated: July 23, 2015

Record last verified: 2015-07

Locations

CA (1)