NCT00189553

Caelyx Plus Carboplatin Versus Paclitaxel Plus Carboplatin in Patients With Epithelial Ovarian Cancer in Late Relapse

A Multi-National,Randomized, Phase III, GCIG Intergroup Study Comparing Pegylated Liposomal Doxorubicin and Carboplatin Versus Paclitaxel and Carboplatin in Patients With Epithelial Ovarian Cancer in Late Relapse (> 6 Months)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 976 (actual)
• Sponsor: ARCAGY/ GINECO GROUP · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a study of the efficacy and safety of Caelyx (pegylated liposomal doxorubicin) in combination with carboplatin compared to the standard treatment of paclitaxel and carboplatin in patients with epithelial ovarian cancer in late relapse (\> 6 months).

Detailed description

The main purpose of this research study is to find out if treatment of late relapse of ovarian or fallopian tube or primary peritoneal cancer with liposomal doxorubicin (Caelyx) combined with carboplatin will control the tumor growth at least as well as standard treatment of paclitaxel and carboplatin. And it is hoped that substituting paclitaxel with Caelyx in combination with carboplatin will improve the tolerance of the treatment program with at least the same efficacy and fewer side effects.

Conditions

• Ovarian Cancer
• Fallopian Tube Cancer

Interventions

Type	Name	Description
DRUG	Pegylated liposomal doxorubicin	30 mg/m² every 4 weeks during 6 cycles or until progression
DRUG	Carboplatin	AUC 5 every 3/4 weeks during 6 cycles or until progression
DRUG	Paclitaxel	175 mg/m² at day 1 every 3 weeks during 6 cycles or until progression

Timeline

• Start date: 2005-04-01
• Primary completion: 2009-01-01
• Completion: 2012-06-01
• First posted: 2005-09-19
• Last updated: 2014-01-10

Locations

1 site across 1 country: France