NCT00006224

Gemcitabine in Treating Patients With Persistent or Recurrent Cancer of the Cervix

Evaluation of Gemcitabine in Persistent or Recurrent Non-Squamous Cell Carcinoma of the Cervix

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: —
• Sponsor: Gynecologic Oncology Group · Network
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of gemcitabine in treating patients who have persistent or recurrent cancer of the cervix.

Detailed description

OBJECTIVES: * Determine the antitumor activity of gemcitabine in patients with persistent or recurrent nonsquamous cell carcinoma of the cervix who failed higher priority treatment protocols. * Determine the toxicity of this regimen in these patients. OUTLINE: This is a multicenter study. Patients receive gemcitabine IV over 30 minutes weekly for 3 weeks. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years and then every 6 months for 3 years. PROJECTED ACCRUAL: Approximately 15-37 patients will be accrued for this study within 1 year.

Conditions

• Cervical Cancer

Interventions

Type	Name	Description
DRUG	gemcitabine hydrochloride

Timeline

• Start date: 2000-09-01
• Primary completion: 2005-04-01
• First posted: 2003-11-11
• Last updated: 2013-04-11

Locations

39 sites across 2 countries: United States, Canada