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

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

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.

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.

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