NCT00066391

Irinotecan and Cisplatin in Treating Patients With Locally Advanced or Metastatic Penile Cancer

Phase II Study of Irinotecan (CPT 11) and Cisplatin (CDDP) in Metastatic or Locally Advanced Penile Carcinoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: —
• Sponsor: European Organisation for Research and Treatment of Cancer - EORTC · Network
• Sex: Male
• Age: 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Penile Cancer

Interventions

Type	Name	Description
DRUG	cisplatin
DRUG	irinotecan hydrochloride
PROCEDURE	neoadjuvant therapy

Timeline

• Start date: 2003-06-01
• Primary completion: 2006-01-01
• First posted: 2003-08-07
• Last updated: 2012-09-24

Locations

8 sites across 6 countries: Belgium, France, Hungary, Netherlands, Poland, United Kingdom