drugset / Trial / NCT00003376
Two-Drug Combination Chemotherapy Compared With Four-Drug Combination Chemotherapy in Treating Patients With Advanced Cancer of the Urothelium
Phase 3
Completed
330 enrolled
Eastern Cooperative Oncology Group
Cancer and Leukemia Group B · collabNational Cancer Institute (NCI) · collab
RandomizedTreatment
Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known if four-drug combination chemotherapy is more effective than two-drug combination chemotherapy in treating advanced cancer of the urothelium. PURPOSE: Randomized phase III trial to compare the effectiveness of four-drug combination chemotherapy with that of two-drug combination chemotherapy in treating patients who have advanced cancer of the urothelium.
Timeline
- Start
- 1998-12-03
- Primary completion
- 2005-09
- Completion
- —
Publications
- Results Dreicer R, Manola J, Roth BJ, See WA, Kuross S, Edelman MJ, Hudes GR, Wilding G. Phase III trial of methotrexate, vinblastine, doxorubicin, and cisplatin versus carboplatin and paclitaxel in patients with advanced carcinoma of the urothelium. Cancer. 2004 Apr 15;100(8):1639-45. doi: 10.1002/cncr.20123.
- Results Dreicer R, Manola J, Roth B, et al.: ECOG 4897: phase III trial of methotrexate, vinblastine, doxorubicin, and cisplatin (M-VAC) versus carboplatin and paclitaxel in patients with advanced carcinoma of the urothelium. [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-1542, 2003.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Carboplatin | Small molecule | — | Intravenous |
| Subject | Cisplatin | Other / unclassified | — | Intravenous |
| Subject | Doxorubicin | Other / unclassified | — | Intravenous |
| Subject | Methotrexate | Small molecule | — | Intravenous |
| Subject | Paclitaxel | Small molecule | 225 mg/m2 | Intravenous |
| Subject | Vinblastine | Small molecule | — | Intravenous |