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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Penile Cancer

Intervention / Treatment
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* Drug: cisplatin
* Drug: irinotecan hydrochloride
* Procedure: neoadjuvant therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 75 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: cisplatin|nan|
|Drug: irinotecan hydrochloride|nan|
|Procedure: neoadjuvant therapy|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate measured by RECIST at 8 weeks after completion of study treatment |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage III penile cancer, penile squamous cell carcinoma, stage IV penile cancer