Carboplatin, Paclitaxel, and Radiation Therapy With or Without Thalidomide in Patients With Stage III Non-small Cell Lung Cancer

Summary

This randomized phase III trial is studying carboplatin, paclitaxel, radiation therapy, and thalidomide to see how well they work compared to carboplatin, paclitaxel, and radiation therapy alone in treating patients with newly diagnosed stage III non-small cell lung cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Thalidomide may stop the growth of non-small cell lung cancer by stopping blood flow to the tumor. It is not yet known if combination chemotherapy plus radiation therapy is more effective with or without thalidomide.

Timeline

Start

2000-01

Primary completion

2009-12

Completion

2010-03

Outcome

Missed primary endpoint

Stopped: “Trial was stopped early for futility”

registry analysis (superiority or other test); Arm A (Paclitaxel + Carboplatin + Radiation ) vs Arm B (Paclitaxel + Carboplatin + Radiation + Thalidomide); p = 0.99; Log Rank NCT00004859 ↗

Publications

• Results Belinsky SA, Grimes MJ, Casas E, Stidley CA, Franklin WA, Bocklage TJ, Johnson DH, Schiller JH. Predicting gene promoter methylation in non-small-cell lung cancer by evaluating sputum and serum. Br J Cancer. 2007 Apr 23;96(8):1278-83. doi: 10.1038/sj.bjc.6603721. Epub 2007 Apr 3.
• Results Belinsky SA, Grimes M, Johnson D, et al.: Predicting gene promoter methylation in lung tumors through examination of sputum and serum. [Abstract] J Clin Oncol 24 (Suppl 18): A-7208, 416s, 2006.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Carboplatin	Small molecule	2 unknown	Intravenous
Subject	Paclitaxel	Small molecule	45 mg/m2	Intravenous
Subject	Thalidomide	Other / unclassified	1000 mg	Oral

Indications