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

Penile Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00066391
• Other study ID #: EORTC-30992
• Secondary ID: EORTC-30992
• Status: Completed
• Phase: Phase 2
• First received: August 6, 2003
• Last updated: September 20, 2012
• Start date: June 2003

Study information

• Verified date: September 2012
• Source: European Organisation for Research and Treatment of Cancer - EORTC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. primary completion date: January 2006
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A to 75 Years

Eligibility

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

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Penile Cancer

Intervention

Drug:
• cisplatin

• irinotecan hydrochloride

Procedure:
• neoadjuvant therapy

Locations

Country	Name	City	State
Belgium	U.Z. Gasthuisberg	Leuven
France	Institut Gustave Roussy	Villejuif
Hungary	National Institute of Oncology	Budapest
Netherlands	Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital	Amsterdam
Poland	Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology	Warsaw
United Kingdom	Bristol Haematology and Oncology Centre	Bristol	England
United Kingdom	Leeds Cancer Centre at St. James's University Hospital	Leeds	England
United Kingdom	Saint Bartholomew's Hospital	London	England

Sponsors (1)

Lead Sponsor	Collaborator
European Organisation for Research and Treatment of Cancer - EORTC

Countries where clinical trial is conducted

Belgium,  France,  Hungary,  Netherlands,  Poland,  United Kingdom, 

References & Publications (1)

Theodore C, Skoneczna I, Bodrogi I, Leahy M, Kerst JM, Collette L, Ven K, Marréaud S, Oliver RD; EORTC Genito-Urinary Tract Cancer Group. A phase II multicentre study of irinotecan (CPT 11) in combination with cisplatin (CDDP) in metastatic or locally adv — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response rate measured by RECIST at 8 weeks after completion of study treatment			No
Secondary	Duration of response as measured by Kaplan-Meier every 8 weeks until progression, and then every 3 months thereafter			No
Secondary	Toxicity as measured by NCI-CTC v2.0 every 8 weeks until progression			Yes