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

Phase 2
18 Years
Not Enrolling
Penile Cancer

Thank you

Trial Information

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


- 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

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

Inclusion Criteria


- 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



- Not specified

Performance status

- Zubrod 0-2

Life expectancy

- Not specified


- 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


- 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


- Not specified


- 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


Biologic therapy

- Not specified


- No prior chemotherapy for penile cancer

Endocrine therapy

- Not specified


- See Disease Characteristics

- At least 28 days since prior radiotherapy and recovered


- Not specified

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate as measured by Response Evaluation Criteria in Solid Tumors (RECIST) criteria every 8 weeks during treatment

Outcome Time Frame:

up to 24 weeks during treatment

Safety Issue:


Principal Investigator

Tomasz M. Beer, MD

Investigator Role:

Study Chair

Investigator Affiliation:

OHSU Knight Cancer Institute


United States: Federal Government

Study ID:




Start Date:

October 2004

Completion Date:

November 2005

Related Keywords:

  • Penile Cancer
  • stage II penile cancer
  • stage III penile cancer
  • stage IV penile cancer
  • Carcinoma, Squamous Cell
  • Penile Neoplasms



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