Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	75 and under	Other	EORTC-30992 NCT00066391

Objectives

1. Determine the anticancer activity of irinotecan and cisplatin in patients with locally advanced or metastatic penile cancer.
2. Determine the objective response rate and duration of response in patients treated with this regimen.
3. Determine the acute side effects of this regimen in these patients.

Entry Criteria

Disease Characteristics:

• Histologically confirmed penile squamous cell carcinoma
  • Locally advanced or metastatic disease
    • T3, N1-2 OR T4, N3, M1



• Measurable disease outside of any previously irradiated field



• No clinical signs of brain metastases

Prior/Concurrent Therapy:

Biologic therapy

• Not specified

Chemotherapy

• No prior chemotherapy

Endocrine therapy

• Not specified

Radiotherapy

• See Disease Characteristics
• More than 4 weeks since prior radiotherapy
• No concurrent radiotherapy for pain control

Surgery

• Not specified

Other

• No other concurrent experimental or anticancer therapy

Patient Characteristics:

Age

• 75 and under

Performance status

• WHO 0-2

Life expectancy

• Not specified

Hematopoietic

• Absolute neutrophil count at least 2,000/mm³
• Platelet count at least 100,000/mm³

Hepatic

• Bilirubin no greater than 1.5 times upper limit of normal (ULN)
• Alkaline phosphatase no greater than 2.5 times ULN (5 times ULN in the presence of liver metastases)
• Transaminases no greater than 2.5 times ULN (5 times ULN in the presence of liver metastases)

Renal

• Glomerular filtration rate at least 60 mL/min

Gastrointestinal

• No chronic diarrhea
• No unresolved bowel obstruction
• No chronic inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis)

Other

• No other prior or concurrent malignancy except adequately treated skin cancer
• No psychological, familial, sociological, or geographical condition that would preclude study compliance and follow-up

Expected Enrollment

A total of 13-28 patients will be accrued for this study.

Outcomes

Objective response rate measured by RECIST at 8 weeks after completion of study treatment

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

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.

Theodore C, Skoneczna I, Bodrogi I, et al.: A phase II multicentre study of irinotecan (CPT 11) in combination with cisplatin (CDDP) in metastatic or locally advanced penile carcinoma (EORTC PROTOCOL 30992). Ann Oncol 19 (7): 1304-7, 2008.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

European Organization for Research and Treatment of Cancer

Christine Theodore, MD, Study coordinator		Ph: 33-1-4625-2149 Email: c.theodore@hopital-foch.org

Registry Information
Official Title		Phase II Study of Irinotecan (CPT 11) and Cisplatin (CDDP) in Metastatic or Locally Advanced Penile Carcinoma
Trial Start Date		2003-06-05
Registered in ClinicalTrials.gov		NCT00066391
Date Submitted to PDQ		2003-06-13
Information Last Verified		2006-01-05

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