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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

  Hide Study Locations
Locations
United States, Colorado
Exempla Lutheran Medical Center
Wheat Ridge, Colorado, United States, 80033
Montrose Memorial Hospital Cancer Center
Montrose, Colorado, United States, 81401
St. Anthony Central Hospital
Denver, Colorado, United States, 80204
Veterans Affairs Medical Center - Denver
Denver, Colorado, United States, 80220
University of Colorado Cancer Center at University of Colorado Health Sciences Center
Denver, Colorado, United States, 80217-3364
St. Anthony North Hospital
Westminster, Colorado, United States, 80030
United States, Kansas
Salina Regional Health Center
Salina, Kansas, United States, 67401
United States, Michigan
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109
United States, Montana
Bozeman Deaconess Hospital
Bozeman, Montana, United States, 59715
CCOP - Montana Cancer Consortium
Billings, Montana, United States, 59101
Community Medical Center
Missoula, Montana, United States, 59801
Deaconess Billings Clinic - Downtown
Billings, Montana, United States, 59101
Deaconess Billings Clinic Cancer Center
Billings, Montana, United States, 59107
Eastern Montana Cancer Center
Miles City, Montana, United States, 59301
Kalispell Regional Medical Center
Kalispell, Montana, United States, 59901
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
Missoula, Montana, United States, 59802
Northern Rockies Radiation Oncology Center
Billings, Montana, United States, 59101
St. James Community Hospital
Butte, Montana, United States, 59701
St. Peter's Hospital
Helena, Montana, United States, 59601
St. Vincent Healthcare
Billings, Montana, United States, 59101
United States, North Carolina
Rutherford Hospital
Rutherfordton, North Carolina, United States, 28139
Wayne Memorial Hospital, Incorporated
Goldsboro, North Carolina, United States, 27534
Wilson Medical Center
Wilson, North Carolina, United States, 27893
United States, Ohio
Licking Memorial Cancer Care Program at Licking Memorial Hospital
Newark, Ohio, United States, 43055
Adena Regional Medical Center
Chillicothe, Ohio, United States, 54601
CCOP - Columbus
Columbus, Ohio, United States, 43215
Cleveland Clinic - Wooster
Wooster, Ohio, United States, 44691
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States, 44195
Community Hospital of Springfield and Clark County
Springfield, Ohio, United States, 45505
Community Oncology Group - Independence
Independence, Ohio, United States, 44131
Doctors Hospital at Ohio Health
Columbus, Ohio, United States, 43228
Mount Carmel Cancer Services at Mount Carmel St. Ann's Hospital
Westerville, Ohio, United States, 43081
Genesis - Good Samaritan Hospital
Zanesville, Ohio, United States, 43701
Grady Memorial Hospital
Delaware, Ohio, United States, 43015
Grant Riverside Cancer Services
Columbus, Ohio, United States, 43215
Mercy Medical Center Oncology Unit
Springfield, Ohio, United States, 45504
Fairfield Medical Center
Lancaster, Ohio, United States, 43130
Mount Carmel West Hospital
Columbus, Ohio, United States, 43222
Riverside Methodist Hospital Cancer Care
Columbus, Ohio, United States, 43214
Strecker Cancer Center at Marietta Memorial Hospital
Marietta, Ohio, United States, 45750
United States, Oklahoma
Oklahoma University Medical Center
Oklahoma City, Oklahoma, United States, 73104
United States, Oregon
Cancer Institute at Oregon Health and Science University
Portland, Oregon, United States, 97239
United States, South Carolina
CCOP - Upstate Carolina
Spartanburg, South Carolina, United States, 29304
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
Spartanburg, South Carolina, United States, 29303
Rose Ramer Cancer Clinic at Anderson Area Medical Center
Anderson, South Carolina, United States, 29621
United States, South Dakota
Avera McKennan Hospital and University Health Center
Sioux Falls, South Dakota, United States, 57105
Medical X-Ray Center
Sioux Falls, South Dakota, United States, 57105
Sioux Valley Hospital and University of South Dakota Medical Center
Sioux Falls, South Dakota, United States, 57104
United States, Wyoming
Welch Cancer Center
Sheridan, Wyoming, United States, 82801
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 25, 2009



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