A Phase II Study of Neo-Adjuvant Cisplatin, Gemcitabine & Bevacizumab, Followed by Radical Cystectomy for Patients With Muscle Invasive, Resectable, Non-Metastatic Transitional Cell Carcinoma (TCC) of the Bladder
Overview
- Phase
- Phase 2
- Intervention
- bevacizumab
- Conditions
- Bladder Cancer
- Sponsor
- Medical University of South Carolina
- Enrollment
- 21
- Locations
- 4
- Primary Endpoint
- Complete Remission Rate
- Status
- Terminated
- Last Updated
- 7 years ago
Overview
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as cisplatin, gemcitabine, and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some find tumor cells and kill them or carry tumor-killing substances to them. Others interfere with the ability of tumor cells to grow and spread. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving combination chemotherapy together with bevacizumab before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving these treatments after surgery may kill any tumor cells that remain after surgery.
PURPOSE: This phase II trial is studying how well giving cisplatin, bevacizumab, and gemcitabine followed by surgery, bevacizumab, and paclitaxel works in treating patients with locally advanced nonmetastatic bladder cancer that can be removed by surgery.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
study intervention
Neo-adjuvant cisplatin, gemcitabine and bevacizumab followed by radical cystectomy. Patients without residual disease will enter follow up after surgery. Patients with residual disease will receive adjuvant therapy with bevacizumab and ciaplatin.
Intervention: bevacizumab
study intervention
Neo-adjuvant cisplatin, gemcitabine and bevacizumab followed by radical cystectomy. Patients without residual disease will enter follow up after surgery. Patients with residual disease will receive adjuvant therapy with bevacizumab and ciaplatin.
Intervention: cisplatin
study intervention
Neo-adjuvant cisplatin, gemcitabine and bevacizumab followed by radical cystectomy. Patients without residual disease will enter follow up after surgery. Patients with residual disease will receive adjuvant therapy with bevacizumab and ciaplatin.
Intervention: gemcitabine hydrochloride
study intervention
Neo-adjuvant cisplatin, gemcitabine and bevacizumab followed by radical cystectomy. Patients without residual disease will enter follow up after surgery. Patients with residual disease will receive adjuvant therapy with bevacizumab and ciaplatin.
Intervention: paclitaxel
study intervention
Neo-adjuvant cisplatin, gemcitabine and bevacizumab followed by radical cystectomy. Patients without residual disease will enter follow up after surgery. Patients with residual disease will receive adjuvant therapy with bevacizumab and ciaplatin.
Intervention: cysectomy
Outcomes
Primary Outcomes
Complete Remission Rate
Time Frame: From day of first treatment until after cycle 3
Secondary Outcomes
- Urinary Survivin Levels(Baseline, week 6 and week 12)
- Urinary Cytogenitics(baseline and week 12)
- Progression Free Survival(from first treatment until time of progression or death, whichever comes first)
- Rate of Post-operative Complications(from first treatment until up to 48 hours after surgery.)
- Median Overall Surivial(from first treatment until death)
- Percentage of Planned Dose Received(from first treatment until end of week 12)