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

Primary Purpose

Penile Cancer

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
docetaxel
Sponsored by
SWOG Cancer Research Network
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Penile Cancer focused on measuring stage II penile cancer, stage III penile cancer, stage IV penile cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • St. Anthony Central Hospital
  • University of Colorado Cancer Center at University of Colorado Health Sciences Center
  • Veterans Affairs Medical Center - Denver
  • Montrose Memorial Hospital Cancer Center
  • St. Anthony North Hospital
  • Exempla Lutheran Medical Center
  • Salina Regional Health Center
  • University of Michigan Comprehensive Cancer Center
  • CCOP - Montana Cancer Consortium
  • Deaconess Billings Clinic - Downtown
  • Northern Rockies Radiation Oncology Center
  • St. Vincent Healthcare
  • Deaconess Billings Clinic Cancer Center
  • Bozeman Deaconess Hospital
  • St. James Community Hospital
  • St. Peter's Hospital
  • Kalispell Regional Medical Center
  • Eastern Montana Cancer Center
  • Community Medical Center
  • Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
  • Wayne Memorial Hospital, Incorporated
  • Rutherford Hospital
  • Wilson Medical Center
  • Adena Regional Medical Center
  • Cleveland Clinic Taussig Cancer Center
  • Riverside Methodist Hospital Cancer Care
  • CCOP - Columbus
  • Grant Riverside Cancer Services
  • Mount Carmel West Hospital
  • Doctors Hospital at Ohio Health
  • Grady Memorial Hospital
  • Community Oncology Group - Independence
  • Fairfield Medical Center
  • Strecker Cancer Center at Marietta Memorial Hospital
  • Licking Memorial Cancer Care Program at Licking Memorial Hospital
  • Mercy Medical Center Oncology Unit
  • Community Hospital of Springfield and Clark County
  • Mount Carmel Cancer Services at Mount Carmel St. Ann's Hospital
  • Cleveland Clinic - Wooster
  • Genesis - Good Samaritan Hospital
  • Oklahoma University Medical Center
  • Cancer Institute at Oregon Health and Science University
  • Rose Ramer Cancer Clinic at Anderson Area Medical Center
  • Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
  • CCOP - Upstate Carolina
  • Sioux Valley Hospital and University of South Dakota Medical Center
  • Avera McKennan Hospital and University Health Center
  • Medical X-Ray Center
  • Welch Cancer Center

Outcomes

Primary Outcome Measures

Response rate as measured by Response Evaluation Criteria in Solid Tumors (RECIST) criteria every 8 weeks during treatment

Secondary Outcome Measures

Safety as measured by Common Terminology Criteria for Adverse Events (CTC) Version 3.0 every 4 weeks

Full Information

First Posted
April 7, 2003
Last Updated
June 27, 2018
Sponsor
SWOG Cancer Research Network
Collaborators
National Cancer Institute (NCI), Eastern Cooperative Oncology Group
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1. Study Identification

Unique Protocol Identification Number
NCT00058448
Brief Title
S0224, Docetaxel in Treating Patients With Locally Advanced or Metastatic Penile Cancer (TERMINATED)
Official Title
Phase II Study Of Weekly Docetaxel In Patients With Advanced Epidermoid Carcinoma Of The Penis
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Terminated
Why Stopped
Study terminated due to poor patient recruitment.
Study Start Date
October 2004 (undefined)
Primary Completion Date
November 2005 (Actual)
Study Completion Date
November 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SWOG Cancer Research Network
Collaborators
National Cancer Institute (NCI), Eastern Cooperative Oncology Group

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Penile Cancer
Keywords
stage II penile cancer, stage III penile cancer, stage IV penile cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
docetaxel
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tomasz M. Beer, MD
Organizational Affiliation
OHSU Knight Cancer Institute
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Roland T. Skeel, MD
Organizational Affiliation
Medical University of Ohio Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
St. Anthony Central Hospital
City
Denver
State/Province
Colorado
ZIP/Postal Code
80204
Country
United States
Facility Name
University of Colorado Cancer Center at University of Colorado Health Sciences Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80217-3364
Country
United States
Facility Name
Veterans Affairs Medical Center - Denver
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
Country
United States
Facility Name
Montrose Memorial Hospital Cancer Center
City
Montrose
State/Province
Colorado
ZIP/Postal Code
81401
Country
United States
Facility Name
St. Anthony North Hospital
City
Westminster
State/Province
Colorado
ZIP/Postal Code
80030
Country
United States
Facility Name
Exempla Lutheran Medical Center
City
Wheat Ridge
State/Province
Colorado
ZIP/Postal Code
80033
Country
United States
Facility Name
Salina Regional Health Center
City
Salina
State/Province
Kansas
ZIP/Postal Code
67401
Country
United States
Facility Name
University of Michigan Comprehensive Cancer Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
CCOP - Montana Cancer Consortium
City
Billings
State/Province
Montana
ZIP/Postal Code
59101
Country
United States
Facility Name
Deaconess Billings Clinic - Downtown
City
Billings
State/Province
Montana
ZIP/Postal Code
59101
Country
United States
Facility Name
Northern Rockies Radiation Oncology Center
City
Billings
State/Province
Montana
ZIP/Postal Code
59101
Country
United States
Facility Name
St. Vincent Healthcare
City
Billings
State/Province
Montana
ZIP/Postal Code
59101
Country
United States
Facility Name
Deaconess Billings Clinic Cancer Center
City
Billings
State/Province
Montana
ZIP/Postal Code
59107
Country
United States
Facility Name
Bozeman Deaconess Hospital
City
Bozeman
State/Province
Montana
ZIP/Postal Code
59715
Country
United States
Facility Name
St. James Community Hospital
City
Butte
State/Province
Montana
ZIP/Postal Code
59701
Country
United States
Facility Name
St. Peter's Hospital
City
Helena
State/Province
Montana
ZIP/Postal Code
59601
Country
United States
Facility Name
Kalispell Regional Medical Center
City
Kalispell
State/Province
Montana
ZIP/Postal Code
59901
Country
United States
Facility Name
Eastern Montana Cancer Center
City
Miles City
State/Province
Montana
ZIP/Postal Code
59301
Country
United States
Facility Name
Community Medical Center
City
Missoula
State/Province
Montana
ZIP/Postal Code
59801
Country
United States
Facility Name
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
City
Missoula
State/Province
Montana
ZIP/Postal Code
59802
Country
United States
Facility Name
Wayne Memorial Hospital, Incorporated
City
Goldsboro
State/Province
North Carolina
ZIP/Postal Code
27534
Country
United States
Facility Name
Rutherford Hospital
City
Rutherfordton
State/Province
North Carolina
ZIP/Postal Code
28139
Country
United States
Facility Name
Wilson Medical Center
City
Wilson
State/Province
North Carolina
ZIP/Postal Code
27893
Country
United States
Facility Name
Adena Regional Medical Center
City
Chillicothe
State/Province
Ohio
ZIP/Postal Code
54601
Country
United States
Facility Name
Cleveland Clinic Taussig Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Riverside Methodist Hospital Cancer Care
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
Facility Name
CCOP - Columbus
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43215
Country
United States
Facility Name
Grant Riverside Cancer Services
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43215
Country
United States
Facility Name
Mount Carmel West Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43222
Country
United States
Facility Name
Doctors Hospital at Ohio Health
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43228
Country
United States
Facility Name
Grady Memorial Hospital
City
Delaware
State/Province
Ohio
ZIP/Postal Code
43015
Country
United States
Facility Name
Community Oncology Group - Independence
City
Independence
State/Province
Ohio
ZIP/Postal Code
44131
Country
United States
Facility Name
Fairfield Medical Center
City
Lancaster
State/Province
Ohio
ZIP/Postal Code
43130
Country
United States
Facility Name
Strecker Cancer Center at Marietta Memorial Hospital
City
Marietta
State/Province
Ohio
ZIP/Postal Code
45750
Country
United States
Facility Name
Licking Memorial Cancer Care Program at Licking Memorial Hospital
City
Newark
State/Province
Ohio
ZIP/Postal Code
43055
Country
United States
Facility Name
Mercy Medical Center Oncology Unit
City
Springfield
State/Province
Ohio
ZIP/Postal Code
45504
Country
United States
Facility Name
Community Hospital of Springfield and Clark County
City
Springfield
State/Province
Ohio
ZIP/Postal Code
45505
Country
United States
Facility Name
Mount Carmel Cancer Services at Mount Carmel St. Ann's Hospital
City
Westerville
State/Province
Ohio
ZIP/Postal Code
43081
Country
United States
Facility Name
Cleveland Clinic - Wooster
City
Wooster
State/Province
Ohio
ZIP/Postal Code
44691
Country
United States
Facility Name
Genesis - Good Samaritan Hospital
City
Zanesville
State/Province
Ohio
ZIP/Postal Code
43701
Country
United States
Facility Name
Oklahoma University Medical Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Cancer Institute at Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Rose Ramer Cancer Clinic at Anderson Area Medical Center
City
Anderson
State/Province
South Carolina
ZIP/Postal Code
29621
Country
United States
Facility Name
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
Facility Name
CCOP - Upstate Carolina
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29304
Country
United States
Facility Name
Sioux Valley Hospital and University of South Dakota Medical Center
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57104
Country
United States
Facility Name
Avera McKennan Hospital and University Health Center
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57105
Country
United States
Facility Name
Medical X-Ray Center
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57105
Country
United States
Facility Name
Welch Cancer Center
City
Sheridan
State/Province
Wyoming
ZIP/Postal Code
82801
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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