S0224, Docetaxel in Treating Patients With Locally Advanced or Metastatic Penile Cancer (TERMINATED)

Penile Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00058448
• Other study ID #: CDR0000297621
• Secondary ID: S0224U10CA032102
• Status: Terminated
• Phase: Phase 2
• 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
• 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

Related Conditions & MeSH terms

• Penile Cancer
• Penile Neoplasms

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