NCT00016926

Capecitabine in Treating Patients With Advanced, Persistent, or Recurrent Cervical Cancer

A Limited Access Phase II Trial Of Capecitabine In Advanced, Persistent Or Recurrent Squamous Cell Carcinoma Of The Cervix

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: —
• Sponsor: Gynecologic Oncology Group · Network
• Sex: Female
• Age: —
• 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 capecitabine in treating patients who have advanced, persistent, or recurrent cervical cancer.

Detailed description

OBJECTIVES: * Determine the activity of capecitabine in patients with advanced, persistent, or recurrent squamous cell carcinoma of the cervix. * Determine the toxicity profile of this drug in this patient population. OUTLINE: This is a multicenter study. Patients receive oral capecitabine twice daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 28-62 patients will be accrued for this study within 9-20 months.

Conditions

• Cervical Cancer

Interventions

Type	Name	Description
DRUG	capecitabine

Timeline

• Start date: 2001-04-01
• Primary completion: 2007-07-01
• First posted: 2003-01-27
• Last updated: 2013-05-27

Locations

10 sites across 2 countries: United States, Norway