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Phase II Study of Docetaxel in Patients With Locally Advanced or Metastatic Epidermoid Carcinoma of the Penis

Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Docetaxel in Treating Patients With Locally Advanced or Metastatic Penile Cancer

Basic Trial Information

Phase
Type
Status
Age
Sponsor
Protocol IDs

Phase II

Treatment

Completed

Not specified

NCI

SWOG-S0224
ECOG-S0224, S0224, NCT00058448

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.

Entry 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

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

Patient Characteristics:

Age

Not specified

Performance status

Zubrod 0-2

Life expectancy

Not specified

Hematopoietic

WBC at least 3,000/mm³
Absolute granulocyte count at least 1,500/mm³
Platelet count at least 100,000/mm³

Hepatic

Bilirubin no greater than upper limit of normal (ULN)
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 recombinant factor VIIa [NovoSeven®])

Expected Enrollment

A total of 20-40 patients will be accrued for this study within 3-5.8 years.

Outcomes

Primary Outcome(s)

Response rate as measured by RECIST criteria every 8 weeks during treatment

Secondary Outcome(s)

Safety as measured by CTC every 4 weeks

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.

Trial Contact Information

Trial Lead Organizations

Southwest Oncology Group

Tomasz Beer, MD, Protocol chair
Ph: 503-494-3253; 800-494-1234

Eastern Cooperative Oncology Group

Roland Skeel, MD, Protocol chair
Ph: 419-383-3727
Email: rskeel@meduohio.edu

Registry Information

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

Trial Start Date		2004-10-15

Registered in ClinicalTrials.gov		NCT00058448

Date Submitted to PDQ		2003-03-03

Information Last Verified		2005-12-01

NCI Grant/Contract Number		CA32102

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.