Combination Chemotherapy Plus Thalidomide in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
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|ClinicalTrials.gov Identifier: NCT00025285|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : April 19, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Drug: carboplatin Drug: irinotecan hydrochloride Drug: thalidomide||Phase 2|
- 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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||46 participants|
|Official Title:||Phase II Study of Carboplatin, Irinotecan, and Thalidomide in Patients With Advanced Non-Small Cell Lung Cancer|
|Actual Study Start Date :||November 2001|
|Actual Primary Completion Date :||September 29, 2004|
|Actual Study Completion Date :||September 29, 2004|
U.S. FDA Resources
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00025285
|United States, Illinois|
|CCOP - Central Illinois|
|Decatur, Illinois, United States, 62526|
|United States, North Carolina|
|Southeastern Medical Oncology Center|
|Goldsboro, North Carolina, United States, 27534-9479|
|Comprehensive Cancer Center at Wake Forest University|
|Winston-Salem, North Carolina, United States, 27157-1082|
|United States, South Carolina|
|CCOP - Greenville|
|Greenville, South Carolina, United States, 29615|
|CCOP - Upstate Carolina|
|Spartanburg, South Carolina, United States, 29303|
|Principal Investigator:||Antonius A. Miller, MD||Wake Forest University Health Sciences|
|Principal Investigator:||James N. Atkins, MD||Southeastern Medical Oncology Center - Goldsboro|