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

Phase 2

Completed

• Conditions: Lung Cancer

• Registration Number: NCT00025285
• Lead Sponsor: Wake Forest University Health Sciences

Brief 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.

Detailed 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 Timeline

• Study First Submitted: 2001-10-11
• Study Start: 2001-11-01
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Primary Completion: 2004-09-29
• Study Completion: 2004-09-29
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-07
• Last Update Posted: 2021-09-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (5)

CCOP - Upstate Carolina; 🇺🇸 Spartanburg, South Carolina, United States

Comprehensive Cancer Center at Wake Forest University; 🇺🇸 Winston-Salem, North Carolina, United States

CCOP - Central Illinois; 🇺🇸 Decatur, Illinois, United States

CCOP - Greenville; 🇺🇸 Greenville, South Carolina, United States

Southeastern Medical Oncology Center; 🇺🇸 Goldsboro, North Carolina, United States