Phase II Study Of Weekly Docetaxel In Patients With Advanced Epidermoid Carcinoma Of The Penis
18 Years
N/A
Male
Penile Cancer
Trial Information
Phase II Study Of Weekly Docetaxel In Patients With Advanced Epidermoid Carcinoma Of The Penis
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Response rate as measured by Response Evaluation Criteria in Solid Tumors (RECIST) criteria every 8 weeks during treatment
Outcome Time Frame:
up to 24 weeks during treatment
Safety Issue:
No
Principal Investigator
Tomasz M. Beer, MD
Investigator Role:
Study Chair
Investigator Affiliation:
OHSU Knight Cancer Institute
Authority:
United States: Federal Government
Study ID:
CDR0000297621
NCT ID:
NCT00058448
Start Date:
October 2004
Completion Date:
November 2005
Related Keywords:
- Penile Cancer
- stage II penile cancer
- stage III penile cancer
- stage IV penile cancer
- Carcinoma, Squamous Cell
- Penile Neoplasms
Name | Location |
|---|---|
| University of Michigan Comprehensive Cancer Center | Ann Arbor, Michigan 48109-0752 |
| CCOP - Upstate Carolina | Spartanburg, South Carolina 29303 |
| CCOP - Montana Cancer Consortium | Billings, Montana 59101 |
| CCOP - Columbus | Columbus, Ohio 43206 |
| University of Colorado Cancer Center at University of Colorado Health Sciences Center | Denver, Colorado 80010 |
| Cleveland Clinic Taussig Cancer Center | Cleveland, Ohio 44195 |
| Veterans Affairs Medical Center - Denver | Denver, Colorado 80220 |
| Cancer Institute at Oregon Health and Science University | Portland, Oregon 97201-3098 |
| Oklahoma University Medical Center | Oklahoma City, Oklahoma 73104 |
| Sioux Valley Hospital and University of South Dakota Medical Center | Sioux Falls, South Dakota 57117-5134 |
| Northern Rockies Radiation Oncology Center | Billings, Montana 59101 |
| St. Vincent Healthcare | Billings, Montana 59101 |
| Deaconess Billings Clinic - Downtown | Billings, Montana 59101 |
| Deaconess Billings Clinic Cancer Center | Billings, Montana 59107 |
| Bozeman Deaconess Hospital | Bozeman, Montana 59715 |
| St. James Community Hospital | Butte, Montana 59701 |
| St. Peter's Hospital | Helena, Montana 59601 |
| Kalispell Regional Medical Center | Kalispell, Montana 59901 |
| Eastern Montana Cancer Center | Miles City, Montana 59301 |
| Montana Cancer Center at St. Patrick Hospital and Health Sciences Center | Missoula, Montana 59802 |
| Community Medical Center | Missoula, Montana 59801 |
| Wayne Memorial Hospital, Incorporated | Goldsboro, North Carolina 27534 |
| Adena Regional Medical Center | Chillicothe, Ohio 54601 |
| Doctors Hospital at Ohio Health | Columbus, Ohio 43228 |
| Riverside Methodist Hospital Cancer Care | Columbus, Ohio 43214 |
| Grant Riverside Cancer Services | Columbus, Ohio 43215 |
| Mount Carmel West Hospital | Columbus, Ohio 43222 |
| Grady Memorial Hospital | Delaware, Ohio 43015 |
| Fairfield Medical Center | Lancaster, Ohio 43130 |
| Strecker Cancer Center at Marietta Memorial Hospital | Marietta, Ohio 45750 |
| Licking Memorial Cancer Care Program at Licking Memorial Hospital | Newark, Ohio 43055 |
| Community Hospital of Springfield and Clark County | Springfield, Ohio 45505 |
| Mercy Medical Center Oncology Unit | Springfield, Ohio 45504 |
| Mount Carmel Cancer Services at Mount Carmel St. Ann's Hospital | Westerville, Ohio 43081 |
| Genesis - Good Samaritan Hospital | Zanesville, Ohio 43701 |
| Avera McKennan Hospital and University Health Center | Sioux Falls, South Dakota 57105 |
| Medical X-Ray Center | Sioux Falls, South Dakota 57105 |
| Welch Cancer Center | Sheridan, Wyoming 82801 |
| Salina Regional Health Center | Salina, Kansas 67401 |
| Wilson Medical Center | Wilson, North Carolina 27893-3428 |
| Cleveland Clinic - Wooster | Wooster, Ohio 44691 |
| St. Anthony Central Hospital | Denver, Colorado 80204-1335 |
| Montrose Memorial Hospital Cancer Center | Montrose, Colorado 81401 |
| St. Anthony North Hospital | Westminster, Colorado 80030 |
| Exempla Lutheran Medical Center | Wheat Ridge, Colorado 80033 |
| Community Oncology Group - Independence | Independence, Ohio 44131 |
| Rose Ramer Cancer Clinic at Anderson Area Medical Center | Anderson, South Carolina 29621 |
| Rutherford Hospital | Rutherfordton, North Carolina 28139 |
| Gibbs Regional Cancer Center at Spartanburg Regional Medical Center | Spartanburg, South Carolina 29303 |
