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

This study has been terminated.
(Study terminated due to poor patient recruitment.)
Sponsor:
Collaborators:
Eastern Cooperative Oncology Group
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT00058448
First received: April 7, 2003
Last updated: April 16, 2013
Last verified: April 2013
  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 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study Of Weekly Docetaxel In Patients With Advanced Epidermoid Carcinoma Of The Penis

Resource links provided by NLM:


Further study details as provided by Southwest Oncology Group:

Primary Outcome Measures:
  • Response rate as measured by Response Evaluation Criteria in Solid Tumors (RECIST) criteria every 8 weeks during treatment [ Time Frame: up to 24 weeks during treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety as measured by Common Terminology Criteria for Adverse Events (CTC) Version 3.0 every 4 weeks [ Time Frame: up to 24 weeks during treatment ] [ Designated as safety issue: Yes ]

Enrollment: 1
Study Start Date: October 2004
Study Completion Date: November 2005
Primary Completion Date: November 2005 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   18 Years and older
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

  • 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

  • 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Show 49 Study Locations
Sponsors and Collaborators
Southwest Oncology Group
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:
No publications provided

Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT00058448     History of Changes
Other Study ID Numbers: CDR0000297621, S0224, U10CA032102
Study First Received: April 7, 2003
Last Updated: April 16, 2013
Health Authority: United States: Federal Government

Keywords provided by Southwest Oncology Group:
stage II penile cancer
stage III penile cancer
stage IV penile cancer

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Penile Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Penile Diseases
Docetaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 26, 2014