drugset / Trial / NCT00077311

Docetaxel and Cisplatin With or Without Dimesna in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer

NCT00077311

RandomizedParallel-groupOpen-labelTreatment

Summary

RATIONALE: Drugs used in chemotherapy, such as docetaxel and cisplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Chemoprotective drugs, such as dimesna, may help prevent or decrease the side effects (such as nerve, kidney, and inner ear damage) caused by chemotherapy. PURPOSE: This randomized phase II trial is studying giving docetaxel and cisplatin together with dimesna to see how well it works compared to giving docetaxel and cisplatin alone in treating patients with stage IIIB or stage IV non-small cell lung cancer.

Timeline

Start
2004-08
Primary completion
2006-07
Completion
2009-04

Drugs

EvaluationDrugModalityDoseRoute
Subject 2,2'-DITHIODIETHANESULFONIC ACID Small molecule 40 g Intravenous
Background Cisplatin Other / unclassified 75 mg/m2 Intravenous
Background Darbepoetin alfa Protein / enzyme biologic 200 ug Subcutaneous
Background Docetaxel Small molecule 75 mg/m2 Intravenous
Background Pegfilgrastim Protein / enzyme biologic 6 mg Subcutaneous