Penile Cancer Clinical Trial
Official title:
Phase II Study of Irinotecan (CPT 11) and Cisplatin (CDDP) in Metastatic or Locally Advanced Penile Carcinoma
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.
Status | Completed |
Enrollment | 0 |
Est. completion date | |
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 |
Masking: Open Label, Primary Purpose: Treatment
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 |
Lead Sponsor | Collaborator |
---|---|
European Organisation for Research and Treatment of Cancer - EORTC |
Belgium, France, Hungary, Netherlands, Poland, United Kingdom,
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
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 |
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