Irinotecan and Cisplatin in Treating Patients With Locally Advanced or Metastatic Penile Cancer
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.
Drug: irinotecan hydrochloride
Procedure: neoadjuvant therapy
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of Irinotecan (CPT 11) and Cisplatin (CDDP) in Metastatic or Locally Advanced Penile Carcinoma|
- Objective response rate measured by RECIST at 8 weeks after completion of study treatment [ Designated as safety issue: No ]
- Duration of response as measured by Kaplan-Meier every 8 weeks until progression, and then every 3 months thereafter [ Designated as safety issue: No ]
- Toxicity as measured by NCI-CTC v2.0 every 8 weeks until progression [ Designated as safety issue: Yes ]
|Study Start Date:||June 2003|
|Primary Completion Date:||January 2006 (Final data collection date for primary outcome measure)|
- 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.
|Leuven, Belgium, B-3000|
|Institut Gustave Roussy|
|Villejuif, France, F-94805|
|National Institute of Oncology|
|Budapest, Hungary, 1122|
|Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital|
|Amsterdam, Netherlands, 1066 CX|
|Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology|
|Warsaw, Poland, 02-781|
|Bristol Haematology and Oncology Centre|
|Bristol, England, United Kingdom, BS2 8ED|
|Leeds Cancer Centre at St. James's University Hospital|
|Leeds, England, United Kingdom, LS9 7TF|
|Saint Bartholomew's Hospital|
|London, England, United Kingdom, EC1A 7BE|
|Study Chair:||Christine Theodore, MD||Institut Gustave Roussy|