Phase II Study of Irinotecan (CPT 11) and Cisplatin (CDDP) in Metastatic or Locally Advanced Penile Carcinoma
N/A
75 Years
Male
Penile Cancer
Trial Information
Phase II Study of Irinotecan (CPT 11) and Cisplatin (CDDP) in Metastatic or Locally Advanced Penile Carcinoma
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Objective response rate measured by RECIST at 8 weeks after completion of study treatment
Safety Issue:
No
Principal Investigator
Christine Theodore, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Gustave Roussy, Cancer Campus, Grand Paris
Authority:
United States: Federal Government
Study ID:
EORTC-30992
NCT ID:
NCT00066391
Start Date:
June 2003
Completion Date:
Related Keywords:
- Penile Cancer
- penile squamous cell carcinoma
- stage III penile cancer
- stage IV penile cancer
- Penile Neoplasms
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