Phase II Evaluation of Trastuzumab (Herceptin), Paclitaxel, Carboplatin, and Gemcitabine in the Treatment of Advanced Urothelial Cancer
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.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Cardiac toxicity rate of this combination using MUGA or 2D ECHO
Up to 7 years
Yes
Maha Hussain
Principal Investigator
University of Michigan University Hospital
United States: Food and Drug Administration
NCI-2012-03187
NCT00005831
March 2000
Name | Location |
---|---|
University of Michigan University Hospital | Ann Arbor, Michigan 48109 |