NCT00248482

Imatinib Mesylate After Irinotecan and Cisplatin in Treating Patients With Extensive-Stage Small Cell Lung Cancer

Phase II Trial of Imatinib Mesylate Maintenance Therapy in Patients With C-Kit (+) Extensive-Stage Small Cell Lung Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Barbara Ann Karmanos Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as irinotecan and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Giving imatinib mesylate after irinotecan and cisplatin may keep the tumor from coming back. PURPOSE: This phase II trial is studying how well giving imatinib mesylate after irinotecan and cisplatin works in treating patients with extensive-stage small cell lung cancer.

Detailed description

OBJECTIVES: Primary * Determine the 4-month progression-free survival rate in patients with c-kit positive, extensive stage small cell lung cancer treated with maintenance therapy comprising imatinib mesylate after induction therapy comprising irinotecan and cisplatin. Secondary * Determine the overall survival of patients treated with this regimen. * Determine the tolerability of imatinib mesylate maintenance therapy in these patients. * Determine the response rate in patients treated with irinotecan and cisplatin. OUTLINE: This is a multicenter study. * Induction therapy: Patients receive irinotecan IV over 90 minutes on days 1 and 8 and cisplatin IV on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a response (partial or complete) or stable disease proceed to maintenance therapy. * Maintenance therapy: Patients receive oral imatinib mesylate twice daily for 6 months in the absence of disease progression or unacceptable toxicity. Some patients may continue to receive therapy for up to 1 year. After completion of study treatment, patients are followed for 4 months. PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study.

Conditions

• Lung Cancer

Interventions

Type	Name	Description
DRUG	Cisplatin	Cisplatin 60mg/m2 IV day 1 every 21 days x 4 cycles
DRUG	Gleevec™	Gleevac 400 mg po BID (800mg/day)- fo patients with objective response or stable disease.
DRUG	irinotecan	Irinotecan: 65 mg/m2 IV days 1, 8 every 21 days x 4 cycles

Timeline

• Start date: 2002-02-01
• Primary completion: 2005-04-01
• Completion: 2008-01-01
• First posted: 2005-11-04
• Last updated: 2013-04-29

Locations

2 sites across 1 country: United States