Phase II Study of Irinotecan (CPT 11) and Cisplatin (CDDP) in Metastatic or Locally Advanced Penile Carcinoma
- Determine the anticancer activity of irinotecan and cisplatin in patients with locally
advanced or metastatic penile cancer.
- Determine the objective response rate and duration of response in patients treated with
- Determine the acute side effects of this regimen in these patients.
OUTLINE: This is an open-label, nonrandomized, multicenter study.
Patients receive irinotecan IV over 30 minutes on days 1, 8, and 15 and cisplatin IV over
1-3 hours on day 1. Courses repeat every 28 days in the absence of disease progression or
unacceptable toxicity. Patients not undergoing local treatment receive up to 8 courses.
Patients planning to undergo surgery receive up to 4 courses.
Patients are followed every 8 weeks until disease progression and then every 3 months
PROJECTED ACCRUAL: A total of 13-28 patients will be accrued for this study.
Masking: Open Label, Primary Purpose: Treatment
Objective response rate measured by RECIST at 8 weeks after completion of study treatment
Christine Theodore, MD
Gustave Roussy, Cancer Campus, Grand Paris
United States: Federal Government