Cisplatin, Gemcitabine and Bevacizumab in Combination for Metastatic Transitional Cell Cancer
Summary
Cisplatin is a very important agent for the treatment of TCC as it has a single agent response rate of approximately 15%. However, it has been most important as a part of combination chemotherapy, MVAC initially and now in combination with gemcitabine. Single agent gemcitabine has demonstrated an overall response rate (ORR) of approximately 25%, including some complete responses (CR), with minimal toxicity in patients with advanced bladder cancer. Bevacizumab, a murine anti-human VEGF monoclonal antibody, has been advanced for use in combination with cytotoxic chemotherapy to delay time to disease progression in patients with metastatic solid tumors. This trial is designed to further assess the efficacy, safety and tolerability of this regimen in this patient population.
Timeline
- Start
- 2005-11
- Primary completion
- 2008-12
- Completion
- 2008-12
Outcome
Missed primary endpoint
paper The study-defined goal of 50% improvement in PFS was not met. PMID 21422406 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bevacizumab | Monoclonal antibody | 15 mg/kg | — |
| Subject | Cisplatin | Other / unclassified | 70 mg/m2 | — |
| Subject | Gemcitabine | Small molecule | 1250 mg/m2 | — |