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

June 27, 2018 updated by: Southwest Oncology Group

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

1

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Denver, Colorado, United States, 80220
        • Veterans Affairs Medical Center - Denver
      • Denver, Colorado, United States, 80204
        • St. Anthony Central Hospital
      • Denver, Colorado, United States, 80217-3364
        • University of Colorado Cancer Center at University of Colorado Health Sciences Center
      • Montrose, Colorado, United States, 81401
        • Montrose Memorial Hospital Cancer Center
      • Westminster, Colorado, United States, 80030
        • St. Anthony North Hospital
      • Wheat Ridge, Colorado, United States, 80033
        • Exempla Lutheran Medical Center
    • Kansas
      • Salina, Kansas, United States, 67401
        • Salina Regional Health Center
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan Comprehensive Cancer Center
    • Montana
      • Billings, Montana, United States, 59101
        • CCOP - Montana Cancer Consortium
      • Billings, Montana, United States, 59101
        • Northern Rockies Radiation Oncology Center
      • Billings, Montana, United States, 59101
        • Deaconess Billings Clinic - Downtown
      • Billings, Montana, United States, 59101
        • St. Vincent Healthcare
      • Billings, Montana, United States, 59107
        • Deaconess Billings Clinic Cancer Center
      • Bozeman, Montana, United States, 59715
        • Bozeman Deaconess Hospital
      • Butte, Montana, United States, 59701
        • St. James Community Hospital
      • Helena, Montana, United States, 59601
        • St. Peter's Hospital
      • Kalispell, Montana, United States, 59901
        • Kalispell Regional Medical Center
      • Miles City, Montana, United States, 59301
        • Eastern Montana Cancer Center
      • Missoula, Montana, United States, 59801
        • Community Medical Center
      • Missoula, Montana, United States, 59802
        • Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
    • North Carolina
      • Goldsboro, North Carolina, United States, 27534
        • Wayne Memorial Hospital, Incorporated
      • Rutherfordton, North Carolina, United States, 28139
        • Rutherford Hospital
      • Wilson, North Carolina, United States, 27893
        • Wilson Medical Center
    • Ohio
      • Chillicothe, Ohio, United States, 54601
        • Adena Regional Medical Center
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Taussig Cancer Center
      • Columbus, Ohio, United States, 43215
        • CCOP - Columbus
      • Columbus, Ohio, United States, 43228
        • Doctors Hospital at Ohio Health
      • Columbus, Ohio, United States, 43214
        • Riverside Methodist Hospital Cancer Care
      • Columbus, Ohio, United States, 43215
        • Grant Riverside Cancer Services
      • Columbus, Ohio, United States, 43222
        • Mount Carmel West Hospital
      • Delaware, Ohio, United States, 43015
        • Grady Memorial Hospital
      • Independence, Ohio, United States, 44131
        • Community Oncology Group - Independence
      • Lancaster, Ohio, United States, 43130
        • Fairfield Medical Center
      • Marietta, Ohio, United States, 45750
        • Strecker Cancer Center at Marietta Memorial Hospital
      • Newark, Ohio, United States, 43055
        • Licking Memorial Cancer Care Program at Licking Memorial Hospital
      • Springfield, Ohio, United States, 45505
        • Community Hospital of Springfield and Clark County
      • Springfield, Ohio, United States, 45504
        • Mercy Medical Center Oncology Unit
      • Westerville, Ohio, United States, 43081
        • Mount Carmel Cancer Services at Mount Carmel St. Ann's Hospital
      • Wooster, Ohio, United States, 44691
        • Cleveland Clinic - Wooster
      • Zanesville, Ohio, United States, 43701
        • Genesis - Good Samaritan Hospital
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Oklahoma University Medical Center
    • Oregon
      • Portland, Oregon, United States, 97239
        • Cancer Institute at Oregon Health and Science University
    • South Carolina
      • Anderson, South Carolina, United States, 29621
        • Rose Ramer Cancer Clinic at Anderson Area Medical Center
      • Spartanburg, South Carolina, United States, 29303
        • Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
      • Spartanburg, South Carolina, United States, 29304
        • CCOP - Upstate Carolina
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57105
        • Medical X-Ray Center
      • Sioux Falls, South Dakota, United States, 57104
        • Sioux Valley Hospital and University of South Dakota Medical Center
      • Sioux Falls, South Dakota, United States, 57105
        • Avera McKennan Hospital and University Health Center
    • Wyoming
      • Sheridan, Wyoming, United States, 82801
        • Welch Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
up to 24 weeks during treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
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
up to 24 weeks during treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Southwest Oncology Group

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2004

Primary Completion (Actual)

November 1, 2005

Study Completion (Actual)

November 1, 2005

Study Registration Dates

First Submitted

April 7, 2003

First Submitted That Met QC Criteria

April 8, 2003

First Posted (Estimate)

April 9, 2003

Study Record Updates

Last Update Posted (Actual)

June 28, 2018

Last Update Submitted That Met QC Criteria

June 27, 2018

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000297621
  • U10CA032102 (U.S. NIH Grant/Contract)
  • S0224 (Other Identifier: SWOG)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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