Phase II Study of Irinotecan (CPT 11) and Cisplatin (CDDP) in Metastatic or Locally Advanced Penile Carcinoma
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.
OBJECTIVES:
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.
DISEASE CHARACTERISTICS:
Histologically confirmed penile squamous cell carcinoma
Locally advanced or metastatic disease
Measurable disease outside of any previously irradiated field
No clinical signs of brain metastases
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Gastrointestinal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other