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Completed

NCT Number: NCT00066391

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

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.

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Key information

Conditions

Penile Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Penile Diseases Penile Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

Up to 75 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

U.Z. Gasthuisberg, Leuven, Belgium

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cisplatin

Drug

irinotecan hydrochloride

Drug

neoadjuvant therapy

Procedure

Primary outcomes

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

Secondary outcomes

  1. Duration of response as measured by Kaplan-Meier every 8 weeks until progression, and then every 3 months thereafter

  2. Toxicity as measured by NCI-CTC v2.0 every 8 weeks until progression

Sponsors and collaborators

Lead sponsor

European Organisation for Research and Treatment of Cancer - EORTC

Network

Registry information

Official study title

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

Important dates

Study start
2003
Primary completion
2006
First posted
Aug 7, 2003
Registry last updated
Sep 24, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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