S0224, Docetaxel in Treating Patients With Locally Advanced or Metastatic Penile Cancer (TERMINATED)

Study Overview
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Brief Summary
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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
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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.

Official Title
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Phase II Study Of Weekly Docetaxel In Patients With Advanced Epidermoid Carcinoma Of The Penis

Conditions
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Penile Cancer

Intervention / Treatment
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* Drug: docetaxel


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: docetaxel|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage II penile cancer, stage III penile cancer, stage IV penile cancer