S0224, Docetaxel in Treating Patients With Locally Advanced or Metastatic Penile Cancer (TERMINATED)
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study Of Weekly Docetaxel In Patients With Advanced Epidermoid Carcinoma Of The Penis|
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: Yes ]
|Study Start Date:||October 2004|
|Study Completion Date:||November 2005|
|Primary Completion Date:||November 2005 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00058448
Show 49 Study Locations
|Study Chair:||Tomasz M. Beer, MD||OHSU Knight Cancer Institute|
|Study Chair:||Roland T. Skeel, MD||Medical University of Ohio Cancer Center|