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:
Southwest Oncology Group
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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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) |
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00058448
Hide Study Locations
Hide Study LocationsLocations
| United States, Colorado | |
| 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 | |
| Montrose Memorial Hospital Cancer Center | |
| Montrose, Colorado, United States, 81401 | |
| St. Anthony North Hospital | |
| Westminster, Colorado, United States, 80030 | |
| Exempla Lutheran Medical Center | |
| Wheat Ridge, Colorado, United States, 80033 | |
| 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 | |
| Deaconess Billings Clinic - Downtown | |
| Billings, Montana, United States, 59101 | |
| CCOP - Montana Cancer Consortium | |
| Billings, Montana, United States, 59101 | |
| Deaconess Billings Clinic Cancer Center | |
| Billings, Montana, United States, 59107 | |
| St. Vincent Healthcare | |
| Billings, Montana, United States, 59101 | |
| Northern Rockies Radiation Oncology Center | |
| Billings, Montana, United States, 59101 | |
| Bozeman Deaconess Hospital | |
| Bozeman, Montana, United States, 59715 | |
| St. James Community Hospital | |
| Butte, Montana, United States, 59701 | |
| St. Peter's Hospital | |
| Helena, Montana, United States, 59601 | |
| Kalispell Regional Medical Center | |
| Kalispell, Montana, United States, 59901 | |
| Eastern Montana Cancer Center | |
| Miles City, Montana, United States, 59301 | |
| Montana Cancer Center at St. Patrick Hospital and Health Sciences Center | |
| Missoula, Montana, United States, 59802 | |
| Community Medical Center | |
| Missoula, Montana, United States, 59801 | |
| United States, North Carolina | |
| Wayne Memorial Hospital, Incorporated | |
| Goldsboro, North Carolina, United States, 27534 | |
| Rutherford Hospital | |
| Rutherfordton, North Carolina, United States, 28139 | |
| Wilson Medical Center | |
| Wilson, North Carolina, United States, 27893 | |
| United States, Ohio | |
| Adena Regional Medical Center | |
| Chillicothe, Ohio, United States, 54601 | |
| Cleveland Clinic Taussig Cancer Center | |
| Cleveland, Ohio, United States, 44195 | |
| CCOP - Columbus | |
| Columbus, Ohio, United States, 43215 | |
| Riverside Methodist Hospital Cancer Care | |
| Columbus, Ohio, United States, 43214 | |
| Doctors Hospital at Ohio Health | |
| Columbus, Ohio, United States, 43228 | |
| Grant Riverside Cancer Services | |
| Columbus, Ohio, United States, 43215 | |
| Mount Carmel West Hospital | |
| Columbus, Ohio, United States, 43222 | |
| Grady Memorial Hospital | |
| Delaware, Ohio, United States, 43015 | |
| Community Oncology Group - Independence | |
| Independence, Ohio, United States, 44131 | |
| Fairfield Medical Center | |
| Lancaster, Ohio, United States, 43130 | |
| Strecker Cancer Center at Marietta Memorial Hospital | |
| Marietta, Ohio, United States, 45750 | |
| Licking Memorial Cancer Care Program at Licking Memorial Hospital | |
| Newark, Ohio, United States, 43055 | |
| Mercy Medical Center Oncology Unit | |
| Springfield, Ohio, United States, 45504 | |
| Community Hospital of Springfield and Clark County | |
| Springfield, Ohio, United States, 45505 | |
| Mount Carmel Cancer Services at Mount Carmel St. Ann's Hospital | |
| Westerville, Ohio, United States, 43081 | |
| Cleveland Clinic - Wooster | |
| Wooster, Ohio, United States, 44691 | |
| Genesis - Good Samaritan Hospital | |
| Zanesville, Ohio, United States, 43701 | |
| 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 | |
| Rose Ramer Cancer Clinic at Anderson Area Medical Center | |
| Anderson, South Carolina, United States, 29621 | |
| CCOP - Upstate Carolina | |
| Spartanburg, South Carolina, United States, 29304 | |
| Gibbs Regional Cancer Center at Spartanburg Regional Medical Center | |
| Spartanburg, South Carolina, United States, 29303 | |
| 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
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 May 19, 2013