S0224, Docetaxel in Treating Patients With Locally Advanced or Metastatic Penile Cancer (TERMINATED)
- Conditions
- Penile Cancer
- Registration Number
- NCT00058448
- Lead Sponsor
- SWOG Cancer Research Network
- Brief Summary
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.
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Male
- Target Recruitment
- 1
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Response rate as measured by Response Evaluation Criteria in Solid Tumors (RECIST) criteria every 8 weeks during treatment up to 24 weeks during treatment
- Secondary Outcome Measures
Name Time Method Safety as measured by Common Terminology Criteria for Adverse Events (CTC) Version 3.0 every 4 weeks up to 24 weeks during treatment
Trial Locations
- Locations (49)
Kalispell Regional Medical Center
🇺🇸Kalispell, Montana, United States
Riverside Methodist Hospital Cancer Care
🇺🇸Columbus, Ohio, United States
Rose Ramer Cancer Clinic at Anderson Area Medical Center
🇺🇸Anderson, South Carolina, United States
St. Anthony Central Hospital
🇺🇸Denver, Colorado, United States
University of Colorado Cancer Center at University of Colorado Health Sciences Center
🇺🇸Denver, Colorado, United States
Veterans Affairs Medical Center - Denver
🇺🇸Denver, Colorado, United States
Montrose Memorial Hospital Cancer Center
🇺🇸Montrose, Colorado, United States
St. Anthony North Hospital
🇺🇸Westminster, Colorado, United States
Exempla Lutheran Medical Center
🇺🇸Wheat Ridge, Colorado, United States
University of Michigan Comprehensive Cancer Center
🇺🇸Ann Arbor, Michigan, United States
Northern Rockies Radiation Oncology Center
🇺🇸Billings, Montana, United States
Bozeman Deaconess Hospital
🇺🇸Bozeman, Montana, United States
St. Peter's Hospital
🇺🇸Helena, Montana, United States
Eastern Montana Cancer Center
🇺🇸Miles City, Montana, United States
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
🇺🇸Missoula, Montana, United States
Wayne Memorial Hospital, Incorporated
🇺🇸Goldsboro, North Carolina, United States
Adena Regional Medical Center
🇺🇸Chillicothe, Ohio, United States
Wilson Medical Center
🇺🇸Wilson, North Carolina, United States
Rutherford Hospital
🇺🇸Rutherfordton, North Carolina, United States
Cleveland Clinic Taussig Cancer Center
🇺🇸Cleveland, Ohio, United States
Mount Carmel West Hospital
🇺🇸Columbus, Ohio, United States
Doctors Hospital at Ohio Health
🇺🇸Columbus, Ohio, United States
Grant Riverside Cancer Services
🇺🇸Columbus, Ohio, United States
Grady Memorial Hospital
🇺🇸Delaware, Ohio, United States
Community Oncology Group - Independence
🇺🇸Independence, Ohio, United States
Fairfield Medical Center
🇺🇸Lancaster, Ohio, United States
Licking Memorial Cancer Care Program at Licking Memorial Hospital
🇺🇸Newark, Ohio, United States
Strecker Cancer Center at Marietta Memorial Hospital
🇺🇸Marietta, Ohio, United States
Community Hospital of Springfield and Clark County
🇺🇸Springfield, Ohio, United States
Mercy Medical Center Oncology Unit
🇺🇸Springfield, Ohio, United States
Mount Carmel Cancer Services at Mount Carmel St. Ann's Hospital
🇺🇸Westerville, Ohio, United States
Genesis - Good Samaritan Hospital
🇺🇸Zanesville, Ohio, United States
Cleveland Clinic - Wooster
🇺🇸Wooster, Ohio, United States
Oklahoma University Medical Center
🇺🇸Oklahoma City, Oklahoma, United States
Cancer Institute at Oregon Health and Science University
🇺🇸Portland, Oregon, United States
CCOP - Upstate Carolina
🇺🇸Spartanburg, South Carolina, United States
Welch Cancer Center
🇺🇸Sheridan, Wyoming, United States
Salina Regional Health Center
🇺🇸Salina, Kansas, United States
Deaconess Billings Clinic Cancer Center
🇺🇸Billings, Montana, United States
CCOP - Montana Cancer Consortium
🇺🇸Billings, Montana, United States
Community Medical Center
🇺🇸Missoula, Montana, United States
St. James Community Hospital
🇺🇸Butte, Montana, United States
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
🇺🇸Spartanburg, South Carolina, United States
Deaconess Billings Clinic - Downtown
🇺🇸Billings, Montana, United States
Medical X-Ray Center
🇺🇸Sioux Falls, South Dakota, United States
Sioux Valley Hospital and University of South Dakota Medical Center
🇺🇸Sioux Falls, South Dakota, United States
Avera McKennan Hospital and University Health Center
🇺🇸Sioux Falls, South Dakota, United States
CCOP - Columbus
🇺🇸Columbus, Ohio, United States
St. Vincent Healthcare
🇺🇸Billings, Montana, United States