drugset / Trial / NCT00091572
Temozolomide Versus Dacarbazine in Stage IV Metastatic Melanoma (Study P03267)
Phase 3
Completed
859 enrolled
Merck Sharp & Dohme LLC
European Organisation for Research and Treatment of Cancer - EORTC · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to ascertain if the extended schedule of Temozolomide, which allows increased doses and potential depletion of the enzyme underlaying resistance, is a more effective treatment of metastatic melanoma than single agent dacarbazine.
Timeline
- Start
- 2004-10-20
- Primary completion
- 2007-12-31
- Completion
- 2007-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Dacarbazine | Small molecule | 1000 mg/m2 | Intravenous |
| Subject | Temozolomide | Small molecule | 150 mg/m2 | Oral |