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

SWOG Cancer Research Network

Status and phase

Terminated

Phase 2

Conditions

Penile Cancer

Treatments

Drug: docetaxel

Study type

Interventional

Funder types

NETWORK

NIH

Identifiers

NCT00058448

CDR0000297621

S0224 (Other Identifier)

U10CA032102 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

1 patient

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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