NCT00006482

Gemcitabine and Cisplatin in Treating Patients With Refractory or Recurrent Cancer of the Cervix

A Phase II Evaluation Of Gemcitabine And Cisplatin In Persistent Or Recurrent Squamous Cell Carcinoma Of The Cervix

• Status: Terminated
• 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. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining gemcitabine and cisplatin in treating patients who have refractory or recurrent cancer of the cervix.

Detailed description

OBJECTIVES: * Determine the antitumor activity of gemcitabine and cisplatin in patients with refractory or recurrent squamous cell carcinoma of the cervix. * Determine the nature and degree of toxicity of this regimen in these patients. OUTLINE: This is a multicenter study. Patients receive cisplatin IV and gemcitabine IV over 1 hour on days 1 and 8. Treatment continues every 28 days 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: A total of 28-69 patients will be accrued for this study.

Conditions

• Cervical Cancer

Interventions

Type	Name	Description
DRUG	cisplatin
DRUG	gemcitabine hydrochloride

Timeline

• Start date: 2000-10-01
• Primary completion: 2006-04-01
• First posted: 2003-10-08
• Last updated: 2013-04-11

Locations

34 sites across 2 countries: United States, Canada