Penile Cancer
Conditions
Keywords
stage II penile cancer, stage III penile cancer, stage IV penile cancer
Brief summary
RATIONALE: Drugs used in chemotherapy such as docetaxel use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of docetaxel in treating patients who have locally advanced or metastatic penile cancer.
Detailed description
OBJECTIVES: * Determine the confirmed complete and partial response rate in patients with locally advanced or metastatic epidermoid carcinoma of the penis treated with docetaxel. * Determine the progression-free and overall survival of patients treated with this drug. * Determine the qualitative and quantitative toxic effects of this drug in these patients. OUTLINE: Patients receive docetaxel IV over 15-30 minutes on days 1, 8, and 15. Treatment repeats every 4 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 1 year and then every 6 months for 2 years. PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study within 3-5.8 years.
Interventions
DRUGdocetaxel
Sponsors
National Cancer Institute (NCI)
Eastern Cooperative Oncology Group
SWOG Cancer Research Network
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Histologically confirmed epidermoid carcinoma of the penis * Distant metastases (M1) OR * Pathologically confirmed regional nodal metastases (N1-3) * Measurable disease * Soft tissue disease irradiated within the past 2 months is not considered measurable disease PATIENT CHARACTERISTICS: Age * Not specified Performance status * Zubrod 0-2 Life expectancy * Not specified Hematopoietic * White blood cell (WBC) count at least 3,000/mm\^3 * Absolute granulocyte count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic * Bilirubin no greater than upper limit of normal (ULN) * Aspartate aminotransferase (SGOT) no greater than 2.5 times ULN * If SGOT is greater than ULN, alkaline phosphatase must be no greater than 2.5 times ULN * Alkaline phosphatase no greater than 4 times ULN * If alkaline phosphatase is greater than ULN, SGOT must be no greater than 1.5 times ULN Renal * Not specified Other * Fertile patients must use effective contraception * No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or stage I or II cancer currently in complete remission * No grade 2 or greater peripheral neuropathy * No hypersensitivity to drugs formulated with polysorbate 80 (e.g., recombinant interferon alfa-2a, multivitamin infusion, etoposide, infliximab, or NovoSeven factor) PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * No prior chemotherapy for penile cancer Endocrine therapy * Not specified Radiotherapy * See Disease Characteristics * At least 28 days since prior radiotherapy and recovered Surgery * Not specified
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate as measured by Response Evaluation Criteria in Solid Tumors (RECIST) criteria every 8 weeks during treatment | up to 24 weeks during treatment |
Secondary
| Measure | Time frame |
|---|---|
| Safety as measured by Common Terminology Criteria for Adverse Events (CTC) Version 3.0 every 4 weeks | up to 24 weeks during treatment |
Countries
United States
Outcome results
None listed