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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00066391
First Posted: August 7, 2003
Last Update Posted: September 24, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC
  Purpose

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.


Condition Intervention Phase
Penile Cancer Drug: cisplatin Drug: irinotecan hydrochloride Procedure: neoadjuvant therapy Phase 2

Study Type: Interventional
Study Design: Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Irinotecan (CPT 11) and Cisplatin (CDDP) in Metastatic or Locally Advanced Penile Carcinoma

Resource links provided by NLM:


Further study details as provided by European Organisation for Research and Treatment of Cancer - EORTC:

Primary Outcome Measures:
  • Objective response rate measured by RECIST at 8 weeks after completion of study treatment

Secondary Outcome Measures:
  • 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

Study Start Date: June 2003
Primary Completion Date: January 2006 (Final data collection date for primary outcome measure)
Detailed Description:

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   up to 75 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00066391


Locations
Belgium
U.Z. Gasthuisberg
Leuven, Belgium, B-3000
France
Institut Gustave Roussy
Villejuif, France, F-94805
Hungary
National Institute of Oncology
Budapest, Hungary, 1122
Netherlands
Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital
Amsterdam, Netherlands, 1066 CX
Poland
Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology
Warsaw, Poland, 02-781
United Kingdom
Bristol Haematology and Oncology Centre
Bristol, England, United Kingdom, BS2 8ED
Leeds Cancer Centre at St. James's University Hospital
Leeds, England, United Kingdom, LS9 7TF
Saint Bartholomew's Hospital
London, England, United Kingdom, EC1A 7BE
Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
Investigators
Study Chair: Christine Theodore, MD Gustave Roussy, Cancer Campus, Grand Paris
  More Information

Publications:
Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier: NCT00066391     History of Changes
Other Study ID Numbers: EORTC-30992
First Submitted: August 6, 2003
First Posted: August 7, 2003
Last Update Posted: September 24, 2012
Last Verified: September 2012

Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
penile squamous cell carcinoma
stage III penile cancer
stage IV penile cancer

Additional relevant MeSH terms:
Penile Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Penile Diseases
Irinotecan
Cisplatin
Camptothecin
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action