Irinotecan and Cisplatin in Treating Patients With Locally Advanced or Metastatic Penile Cancer
- Conditions
- Penile Cancer
- Registration Number
- NCT00066391
- Brief Summary
RATIONALE: Drugs used in chemotherapy such as irinotecan and cisplatin use different ways to stop tumor cells from dividing so they stop growing or die. Combining irinotecan with cisplatin may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining irinotecan with cisplatin in treating patients who have locally advanced or metastatic penile cancer.
- Detailed Description
OBJECTIVES:
* 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 this regimen.
* 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 thereafter.
PROJECTED ACCRUAL: A total of 13-28 patients will be accrued for this study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Objective response rate measured by RECIST at 8 weeks after completion of study treatment
- Secondary Outcome Measures
Name Time Method Duration of response as measured by Kaplan-Meier every 8 weeks until progression, and then every 3 months thereafter Toxicity as measured by NCI-CTC v2.0 every 8 weeks until progression
Trial Locations
- Locations (8)
Bristol Haematology and Oncology Centre
🇬🇧Bristol, England, United Kingdom
U.Z. Gasthuisberg
🇧🇪Leuven, Belgium
National Institute of Oncology
ðŸ‡ðŸ‡ºBudapest, Hungary
Leeds Cancer Centre at St. James's University Hospital
🇬🇧Leeds, England, United Kingdom
Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital
🇳🇱Amsterdam, Netherlands
Saint Bartholomew's Hospital
🇬🇧London, England, United Kingdom
Institut Gustave Roussy
🇫🇷Villejuif, France
Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology
🇵🇱Warsaw, Poland