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

European Organisation for Research and Treatment of Cancer - EORTC

Overview

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.

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.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Masking

NONE

Conditions

Penile Cancer

Interventions

cisplatinDRUG

irinotecan hydrochlorideDRUG

neoadjuvant therapyPROCEDURE

Eligibility

Sex: MALEMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (8)

U.Z. Gasthuisberg

Leuven, Belgium

Institut Gustave Roussy

Villejuif, France

National Institute of Oncology

Budapest, Hungary

Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital

Amsterdam, Netherlands

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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