A Phase III Randomized, Double Blind, Placebo Controlled Trial Of Carboplatin/Etoposide With Or Without Thalidomide In Small Cell Lung Cancer (Study 12)

Brief Summary

Detailed Description

OBJECTIVES: * Compare the survival of patients with limited or extensive stage small cell lung cancer treated with carboplatin and etoposide with vs without thalidomide. * Compare the time to disease progression in patients treated with these regimens. * Compare the toxicity of these regimens in these patients. * Compare the response rates of patients treated with these regimens. * Compare the quality of life of patients treated with these regimens. OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to disease stage (limited vs extensive), ECOG performance status (0 and 1 vs 2), and alkaline phosphatase (no greater than 1.5 times upper limit of normal \[ULN\] vs greater than 1.5 times ULN). Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive carboplatin IV over 30 minutes on day 1 and etoposide\* IV over 1-2 hours on days 1 and 2 and orally on day 3. Patients also receive oral thalidomide daily beginning on day 1. * Arm II: Patients receive carboplatin and etoposide as in arm I and oral placebo daily beginning on day 1. NOTE: \*Patients who are unable to receive etoposide IV on day 2 may receive oral etoposide on days 2 and 3. In both arms, chemotherapy (carboplatin and etoposide) repeats every 3 weeks for up to 6 courses. Patients receive thalidomide or placebo continuously for up to 2 years. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients who experience disease progression may continue to receive thalidomide or placebo provided the patient is clinically and symptomatically stable. Quality of life is assessed at baseline, during each course of chemotherapy, at 3-4 weeks after completion of chemotherapy, and at 6, 12, 18, and 24 months. Patients are followed every 2 months for 2 years after the completion of chemotherapy and then every 3 months thereafter. Peer Reviewed and Funded or Endorsed by Cancer Research UK PROJECTED ACCRUAL: A total of 372 patients (186 per treatment arm) will be accrued for this study.

Primary Outcomes

Secondary Outcomes

• Time to disease progression 2 years after study randomization(0-2 years)
• Toxicity as measured by NCIC CTC 3 times weekly while undergoing chemotherapy, then monthly thereafter(Till end of treatment)
• Response rates as measured by RECIST during each visit while undergoing chemotherapy and after completion of study treatment(Till progression)
• Quality of life as measured by EORTC QLQ-30 and lung-specific questionnaire(LC14) at baseline, after each course, and after completion of study treatment, and at 6, 12, 18, and 24 months after day 1 of course 1(0-24 months)
• Biological markers (measurement of VEGF, bFGF, TNF alpha, and IL-6)(Before treatment courses 1 and 4, and then at 9 and 18 months)