Carboplatin and Etoposide With or Without Thalidomide in Treating Patients With Limited-Stage or Extensive-Stage Small Cell Lung Cancer

Summary

RATIONALE: Drugs used in chemotherapy such as carboplatin and etoposide use different ways to stop tumor cells from dividing so they stop growing or die. Thalidomide may stop the growth of cancer by stopping blood flow to the tumor. It is not yet known if combination chemotherapy is more effective with or without thalidomide in treating small cell lung cancer. PURPOSE: This randomized phase III trial is studying carboplatin, etoposide, and thalidomide to see how well they work compared to carboplatin and etoposide in treating patients with limited- or extensive-stage small cell lung cancer.

Timeline

Start

2003-04

Primary completion

2007-02

Completion

2007-07

Outcome

Missed primary endpoint

paper The median overall survival was 10.5 months (placebo) and 10.1 months (thalidomide) (HR for death = 1.09, 95% confidence interval [CI] = 0.93 to 1.27; P = .28). PMID 19608997 ↗

paper thalidomide in combination with chemotherapy did not improve survival of patients with SCLC PMID 19608997 ↗

Publications

• Results Lee SM, Woll PJ, Rudd R, Ferry D, O'Brien M, Middleton G, Spiro S, James L, Ali K, Jitlal M, Hackshaw A. Anti-angiogenic therapy using thalidomide combined with chemotherapy in small cell lung cancer: a randomized, double-blind, placebo-controlled trial. J Natl Cancer Inst. 2009 Aug 5;101(15):1049-57. doi: 10.1093/jnci/djp200. Epub 2009 Jul 16.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Thalidomide	Other / unclassified	—	Oral
Background	Carboplatin	Small molecule	—	Intravenous
Background	Etoposide	Small molecule	—	Intravenous

Indications