Clinical Trials Directory

Trials / Terminated

TerminatedNCT00058448

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

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

Status
Terminated
Phase
Phase 2
Study type
Interventional
Enrollment
1 (actual)
Sponsor
SWOG Cancer Research Network · Network
Sex
Male
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGdocetaxel

Timeline

Start date
2004-10-01
Primary completion
2005-11-01
Completion
2005-11-01
First posted
2003-04-09
Last updated
2018-06-28

Locations

49 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT00058448. Inclusion in this directory is not an endorsement.