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

NCT00189553 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 976

Last updated 2014-01-10

No results posted yet for this study

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).

Conditions

Interventions

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

Sponsors & Collaborators

  • Schering-Plough

    collaborator INDUSTRY

  • Arbeitsgemeinschaft Gynaekologische Onkologie Austria

    collaborator OTHER

  • AGO Study Group

    collaborator OTHER

  • Australia New Zealand Gynaecological Oncology Group

    collaborator OTHER

  • European Organisation for Research and Treatment of Cancer - EORTC

    collaborator NETWORK

  • NCIC Clinical Trials Group

    collaborator NETWORK

  • NSGO

    collaborator UNKNOWN

  • ARCAGY/ GINECO GROUP

    lead OTHER

Principal Investigators

  • Eric Pujade-Lauraine, MD, PhD · GINECO GROUP

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-04-30
Primary Completion
2009-01-31
Completion
2012-06-30

Countries

  • France

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00189553 on ClinicalTrials.gov