Clinical Trial: S0224, Docetaxel in Treating Patients With Locally Advanced or Metastatic Penile Cancer (TERMINATED)
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: Phase II Study Of Weekly Docetaxel In Patients With Advanced Epidermoid Carcinoma Of The Penis
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 Summary:
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.
Sponsor: Southwest Oncology Group
Current Primary Outcome: 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 ]
Original Primary Outcome:
Current Secondary Outcome: 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 ]
Original Secondary Outcome:
Information By: Southwest Oncology Group
Dates:
Date Received: April 7, 2003
Date Started: October 2004
Date Completion:
Last Updated: April 16, 2013
Last Verified: April 2013
