drugset / Trial / NCT00077311
Docetaxel and Cisplatin With or Without Dimesna in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
Phase 2
Completed
160 enrolled
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI) · collab
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |