Know Cancer

or
forgot password

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


Phase 2
18 Years
N/A
Not Enrolling
Male
Penile Cancer

Thank you

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 CenterAnn Arbor, Michigan  48109-0752
CCOP - Upstate CarolinaSpartanburg, South Carolina  29303
CCOP - Montana Cancer ConsortiumBillings, Montana  59101
CCOP - ColumbusColumbus, Ohio  43206
University of Colorado Cancer Center at University of Colorado Health Sciences CenterDenver, Colorado  80010
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
Veterans Affairs Medical Center - DenverDenver, Colorado  80220
Cancer Institute at Oregon Health and Science UniversityPortland, Oregon  97201-3098
Oklahoma University Medical CenterOklahoma City, Oklahoma  73104
Sioux Valley Hospital and University of South Dakota Medical CenterSioux Falls, South Dakota  57117-5134
Northern Rockies Radiation Oncology CenterBillings, Montana  59101
St. Vincent HealthcareBillings, Montana  59101
Deaconess Billings Clinic - DowntownBillings, Montana  59101
Deaconess Billings Clinic Cancer CenterBillings, Montana  59107
Bozeman Deaconess HospitalBozeman, Montana  59715
St. James Community HospitalButte, Montana  59701
St. Peter's HospitalHelena, Montana  59601
Kalispell Regional Medical CenterKalispell, Montana  59901
Eastern Montana Cancer CenterMiles City, Montana  59301
Montana Cancer Center at St. Patrick Hospital and Health Sciences CenterMissoula, Montana  59802
Community Medical CenterMissoula, Montana  59801
Wayne Memorial Hospital, IncorporatedGoldsboro, North Carolina  27534
Adena Regional Medical CenterChillicothe, Ohio  54601
Doctors Hospital at Ohio HealthColumbus, Ohio  43228
Riverside Methodist Hospital Cancer CareColumbus, Ohio  43214
Grant Riverside Cancer ServicesColumbus, Ohio  43215
Mount Carmel West HospitalColumbus, Ohio  43222
Grady Memorial HospitalDelaware, Ohio  43015
Fairfield Medical CenterLancaster, Ohio  43130
Strecker Cancer Center at Marietta Memorial HospitalMarietta, Ohio  45750
Licking Memorial Cancer Care Program at Licking Memorial HospitalNewark, Ohio  43055
Community Hospital of Springfield and Clark CountySpringfield, Ohio  45505
Mercy Medical Center Oncology UnitSpringfield, Ohio  45504
Mount Carmel Cancer Services at Mount Carmel St. Ann's HospitalWesterville, Ohio  43081
Genesis - Good Samaritan HospitalZanesville, Ohio  43701
Avera McKennan Hospital and University Health CenterSioux Falls, South Dakota  57105
Medical X-Ray CenterSioux Falls, South Dakota  57105
Welch Cancer CenterSheridan, Wyoming  82801
Salina Regional Health CenterSalina, Kansas  67401
Wilson Medical CenterWilson, North Carolina  27893-3428
Cleveland Clinic - WoosterWooster, Ohio  44691
St. Anthony Central HospitalDenver, Colorado  80204-1335
Montrose Memorial Hospital Cancer CenterMontrose, Colorado  81401
St. Anthony North HospitalWestminster, Colorado  80030
Exempla Lutheran Medical CenterWheat Ridge, Colorado  80033
Community Oncology Group - IndependenceIndependence, Ohio  44131
Rose Ramer Cancer Clinic at Anderson Area Medical CenterAnderson, South Carolina  29621
Rutherford HospitalRutherfordton, North Carolina  28139
Gibbs Regional Cancer Center at Spartanburg Regional Medical CenterSpartanburg, South Carolina  29303