Penile Cancer
Conditions
Keywords
penile squamous cell carcinoma, stage III penile cancer, stage IV penile cancer
Brief 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.
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.
Interventions
DRUGcisplatin
DRUGirinotecan hydrochloride
PROCEDUREneoadjuvant therapy
Sponsors
European Organisation for Research and Treatment of Cancer - EORTC
Study design
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
No minimum to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate measured by RECIST at 8 weeks after completion of study treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of response as measured by Kaplan-Meier every 8 weeks until progression, and then every 3 months thereafter | — |
| Toxicity as measured by NCI-CTC v2.0 every 8 weeks until progression | — |
Countries
Belgium, France, Hungary, Netherlands, Poland, United Kingdom
Outcome results
None listed