At a glance
ClinicalIndex Comparison Record- ✓Previously untreated OR relapsed locally advanced or metastatic transitional cell carcinoma of bladder
- ✓Relapsed patients may have received prior chemotherapy ≥1 year before study entry as part of neoadjuvant/adjuvant regimen with no intervening therapy
- ✓Pure transitional cell histology (ANY non-transitional cell component excludes patient)
- ✓Measurable disease as per RECIST
- ✕Known central nervous system metastasis
- ✕Prior organ allograft
- ✕Evidence of bleeding diathesis or coagulopathy
- ✕History of serious, non-healing wound, ulcer, or bone fracture
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II Trial of Cisplatin, Gemcitabine and Bevacizumab in Combination for Metastatic Transitional Cell Cancer: Hoosier Oncology Group GU04-75
In Brief
A Phase 2 clinical trial evaluating Cisplatin, Gemcitabine, and 1 other intervention for Bladder Cancer. Completed, enrolled 45 participants across 11 sites.
Detailed 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.
Study Details
Timeline
Interventions
Cisplatin 70 mg/m2, day 1
Gemcitabine 1250 mg/m2, day 1 and 8
Bevacizumab 15mg/kg, day 1