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Docetaxel in Treating Patients With Locally Advanced or Metastatic Penile Cancer
This study has been completed.
First Received: April 7, 2003   Last Updated: April 4, 2009   History of Changes
Sponsor: Southwest Oncology Group
Collaborators: 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

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

Resource links provided by NLM:

MedlinePlus related topics: Cancer
Drug Information available for: Docetaxel
U.S. FDA Resources

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 OHSU Knight Cancer Institute
Study Chair: Roland T. Skeel, MD Medical University of Ohio Cancer Center
  More Information

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

No publications provided

Study ID Numbers: CDR0000297621, SWOG-S0224, ECOG-S0224
Study First Received: April 7, 2003
Last Updated: April 4, 2009
ClinicalTrials.gov Identifier: NCT00058448     History of Changes
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

Additional relevant MeSH terms:
Docetaxel
Neoplasms
Neoplasms by Site
Genital Neoplasms, Male
Antineoplastic Agents
Therapeutic Uses
 Urogenital Neoplasms
Penile Neoplasms
Genital Diseases, Male
Penile Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 05, 2009



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