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Combination Chemotherapy Plus Thalidomide in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer

Lung Cancer Clinical Trial

Official title:
Phase II Study of Carboplatin, Irinotecan, and Thalidomide in Patients With Advanced Non-Small Cell Lung Cancer

Clinical Trial Summary

RATIONALE: Thalidomide may stop the growth of cancer by stopping blood flow to the tumor. Combining thalidomide with chemotherapy may kill more tumor cells and be an effective treatment for stage IIIB or stage IV non-small cell lung cancer. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus thalidomide in treating patients who have stage IIIB or stage IV non-small cell lung cancer.

Clinical Trial Description

OBJECTIVES: - Determine the response rate and duration of response in patients with stage IIIB or IV non-small cell lung cancer treated with carboplatin, irinotecan, and thalidomide. - Determine the progression-free and overall survival of patients treated with this regimen. - Evaluate the toxicity profile of this regimen in these patients. OUTLINE: Patients receive carboplatin IV over 30 minutes on day 1 and irinotecan IV over 90 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with stable or responsive disease receive up to 6 courses of therapy. Patients also receive oral thalidomide once daily beginning on day 1 and continuing until disease progression. Patients are followed every 3 months until disease progression and then every 6 months thereafter. PROJECTED ACCRUAL: A total of 39-70 patients will be accrued for this study within 14 months. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00025285
Study type Interventional
Source Wake Forest University Health Sciences
Contact
Status Completed
Phase Phase 2
Start date November 1, 2001
Completion date September 29, 2004
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