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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00058448
Other study ID # CDR0000297621
Secondary ID S0224U10CA032102
Status Terminated
Phase Phase 2
First received
Last updated
Start date October 2004
Est. completion date November 2005

Study information

Verified date April 2013
Source Southwest Oncology Group
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 information / eligibility

Status Terminated
Enrollment 1
Est. completion date November 2005
Est. primary completion date November 2005
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
docetaxel


Locations

Country Name City State
United States Rose Ramer Cancer Clinic at Anderson Area Medical Center Anderson South Carolina
United States University of Michigan Comprehensive Cancer Center Ann Arbor Michigan
United States CCOP - Montana Cancer Consortium Billings Montana
United States Deaconess Billings Clinic - Downtown Billings Montana
United States Deaconess Billings Clinic Cancer Center Billings Montana
United States Northern Rockies Radiation Oncology Center Billings Montana
United States St. Vincent Healthcare Billings Montana
United States Bozeman Deaconess Hospital Bozeman Montana
United States St. James Community Hospital Butte Montana
United States Adena Regional Medical Center Chillicothe Ohio
United States Cleveland Clinic Taussig Cancer Center Cleveland Ohio
United States CCOP - Columbus Columbus Ohio
United States Doctors Hospital at Ohio Health Columbus Ohio
United States Grant Riverside Cancer Services Columbus Ohio
United States Mount Carmel West Hospital Columbus Ohio
United States Riverside Methodist Hospital Cancer Care Columbus Ohio
United States Grady Memorial Hospital Delaware Ohio
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 Wayne Memorial Hospital, Incorporated Goldsboro North Carolina
United States St. Peter's Hospital Helena Montana
United States Community Oncology Group - Independence Independence Ohio
United States Kalispell Regional Medical Center Kalispell Montana
United States Fairfield Medical Center Lancaster Ohio
United States Strecker Cancer Center at Marietta Memorial Hospital Marietta Ohio
United States Eastern Montana Cancer Center Miles City Montana
United States Community Medical Center Missoula Montana
United States Montana Cancer Center at St. Patrick Hospital and Health Sciences Center Missoula Montana
United States Montrose Memorial Hospital Cancer Center Montrose Colorado
United States Licking Memorial Cancer Care Program at Licking Memorial Hospital Newark Ohio
United States Oklahoma University Medical Center Oklahoma City Oklahoma
United States Cancer Institute at Oregon Health and Science University Portland Oregon
United States Rutherford Hospital Rutherfordton North Carolina
United States Salina Regional Health Center Salina Kansas
United States Welch Cancer Center Sheridan Wyoming
United States Avera McKennan Hospital and University Health Center Sioux Falls South Dakota
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 CCOP - Upstate Carolina Spartanburg South Carolina
United States Gibbs Regional Cancer Center at Spartanburg Regional Medical Center Spartanburg South Carolina
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 St. Anthony North Hospital Westminster Colorado
United States Exempla Lutheran Medical Center Wheat Ridge Colorado
United States Wilson Medical Center Wilson North Carolina
United States Cleveland Clinic - Wooster Wooster Ohio
United States Genesis - Good Samaritan Hospital Zanesville Ohio

Sponsors (3)

Lead Sponsor Collaborator
Southwest Oncology Group Eastern Cooperative Oncology Group, National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Safety as measured by Common Terminology Criteria for Adverse Events (CTC) Version 3.0 every 4 weeks up to 24 weeks during treatment
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