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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary:

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.


Sponsor: European Organisation for Research and Treatment of Cancer - EORTC

Current Primary Outcome: Objective response rate measured by RECIST at 8 weeks after completion of study treatment

Original Primary Outcome:

Current Secondary Outcome:

  • 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


Original Secondary Outcome:

Information By: European Organisation for Research and Treatment of Cancer - EORTC

Dates:
Date Received: August 6, 2003
Date Started: June 2003
Date Completion:
Last Updated: September 20, 2012
Last Verified: September 2012