Stage IV Bladder Cancer Clinical Trial
Official title:
Phase II Evaluation of Trastuzumab (Herceptin), Paclitaxel, Carboplatin, and Gemcitabine in the Treatment of Advanced Urothelial Cancer
Phase II trial to study the effectiveness of combining trastuzumab with combination chemotherapy in treating patients who have locally recurrent or metastatic urinary tract cancer. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining monoclonal antibody therapy with combination chemotherapy may kill more tumor cells
PRIMARY OBJECTIVES:
I. To assess the toxicity of the combination of Herceptin, paclitaxel, carboplatin, and
gemcitabine in patients with metastatic or locally recurrent urothelial cancers who
overexpress HER2.
SECONDARY OBJECTIVES:
I. The complete and partial response rates. II. The median and overall survival. III. To
prospectively evaluate the percentage of patients with metastatic/recurrent bladder cancer
who overexpress HER2 histologically (by immunohistochemistry and FISH) and serologically.
IV. To generate preliminary data on response to other therapy and survival for Her2 negative
patients.
OUTLINE:
Patients receive trastuzumab (Herceptin) IV over 30-90 minutes on days 1, 8, and 15;
paclitaxel IV over 3 hours and carboplatin IV over 15 minutes on day 1; and gemcitabine IV
over 30 minutes on days 1 and 8. Courses repeat every 3 weeks. Patients achieving a complete
response (CR) receive 3 courses past CR. Patients achieving a partial response or stable
disease continue on therapy until CR or disease progression or unacceptable toxicity.
Patients are followed for disease progression and survival. Patients with HER2-negative
disease are not eligible for treatment but are followed every 6 months for response and
survival.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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