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Docetaxel in Treating Patients With Locally Advanced or Metastatic Penile Cancer
This study has been completed.
Sponsors and Collaborators: Southwest Oncology Group
National Cancer Institute (NCI)
Eastern Cooperative Oncology Group
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00058448
  Purpose

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.


Condition Intervention Phase
Penile Cancer
 Drug: docetaxel
 Phase II

MedlinePlus related topics: Cancer
Drug Information available for: Docetaxel
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: Phase II Study Of Weekly Docetaxel In Patients With Advanced Epidermoid Carcinoma Of The Penis

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Response rate as measured by RECIST criteria every 8 weeks during treatment [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety as measured by CTC every 4 weeks [ Designated as safety issue: Yes ]

Study Start Date: October 2004
Detailed 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.

  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

  • WBC 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)

  • 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®])

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00058448

  Show 49 Study Locations
Sponsors and Collaborators
Southwest Oncology Group
National Cancer Institute (NCI)
Eastern Cooperative Oncology Group
Investigators
Study Chair: Tomasz M. Beer, MD Oregon Health and Science University Cancer Institute
Study Chair: Roland T. Skeel, MD Medical University of Ohio Cancer Center
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000297621, SWOG-S0224, ECOG-S0224
Study First Received: April 7, 2003
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00058448  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage II penile cancer
stage III penile cancer
stage IV penile cancer

Study placed in the following topic categories:
Docetaxel
Epidermoid carcinoma
Genital Neoplasms, Male
Squamous cell carcinoma
Carcinoma, squamous cell
 Urogenital Neoplasms
Penile Neoplasms
Genital Diseases, Male
Carcinoma, Squamous Cell
Carcinoma

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Antineoplastic Agents
 Therapeutic Uses
Penile Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009



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