Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

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.

Further Study Information

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.

Eligibility 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

PATIENT CHARACTERISTICS:

Age

• 75 and under

Performance status

• WHO 0-2

Life expectancy

• Not specified

Hematopoietic

• Absolute neutrophil count at least 2,000/mm^3

• Platelet count at least 100,000/mm^3

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

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

Trial Contact Information

Trial Lead Organizations/Sponsors

European Organization for Research and Treatment of Cancer

Christine Theodore

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00066391
Information obtained from ClinicalTrials.gov on December 18, 2011

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