Penile Cancer Clinical Trial
Official title:
Phase II Study Of Weekly Docetaxel In Patients With Advanced Epidermoid Carcinoma Of The Penis
RATIONALE: Drugs used in chemotherapy such as docetaxel use different ways to stop tumor
cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of docetaxel in treating patients who have
locally advanced or metastatic penile cancer.
OBJECTIVES:
- Determine the confirmed complete and partial response rate in patients with locally
advanced or metastatic epidermoid carcinoma of the penis treated with docetaxel.
- Determine the progression-free and overall survival of patients treated with this drug.
- Determine the qualitative and quantitative toxic effects of this drug in these patients.
OUTLINE: Patients receive docetaxel IV over 15-30 minutes on days 1, 8, and 15. Treatment
repeats every 4 weeks for up to 6 courses in the absence of disease progression or
unacceptable toxicity.
Patients are followed every 3 months for 1 year and then every 6 months for 2 years.
PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study within 3-5.8
years.
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