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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier:
NCT00066391
First received: August 6, 2003
Last updated: September 20, 2012
Last verified: September 2012
  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: 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 [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Duration of response as measured by Kaplan-Meier every 8 weeks until progression, and then every 3 months thereafter [ Designated as safety issue: No ]
  • Toxicity as measured by NCI-CTC v2.0 every 8 weeks until progression [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   up to 75 Years
Genders 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

Additional 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, EORTC-30992
Study First Received: August 6, 2003
Last Updated: September 20, 2012
Health Authority: United States: Federal Government

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:
Irinotecan
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Antineoplastic Agents, Phytogenic
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014