NCT00030472

Liposomal Doxorubicin in Treating Patients With Persistent or Recurrent Cancer of the Cervix

A Phase II Evaluation of Liposomal Doxorubicin (Doxil) in the Treatment of 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. PURPOSE: Phase II trial to study the effectiveness liposomal doxorubicin in treating patients who have persistent or recurrent cancer of the cervix.

Detailed description

OBJECTIVES: * Determine the antitumor activity of doxorubicin HCl liposome in patients with persistent or recurrent squamous cell carcinoma of the cervix. * Determine the toxicity of this drug in these patients. OUTLINE: This is a multicenter study. Patients receive doxorubicin HCl liposome IV over 1 hour on day 1. Treatment repeats every 28 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 22-60 patients will be accrued for this study.

Conditions

• Cervical Cancer

Interventions

Type	Name	Description
DRUG	pegylated liposomal doxorubicin hydrochloride

Timeline

• Start date: 2001-12-01
• Primary completion: 2006-10-01
• First posted: 2003-01-27
• Last updated: 2013-04-11

Locations

17 sites across 2 countries: United States, Norway