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

Phase 3

Completed

• Conditions: Ovarian Cancer; Fallopian Tube Cancer
• Interventions: Drug: Pegylated liposomal doxorubicin; Drug: Carboplatin; Drug: Paclitaxel

• Registration Number: NCT00189553
• Lead Sponsor: ARCAGY/ GINECO GROUP

Brief 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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2005-04
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-19
• Primary Completion: 2009-01
• Study Completion: 2012-06
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-09
• Last Update Posted: 2014-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 976

Inclusion Criteria

• Patients aged > 18
• Histologically proven diagnosis of cancer of the ovary, the fallopian tube or extra-ovarian papillary serous tumors
• Measurable disease (Response Evaluation Criteria in Solid Tumor [RECIST] criteria) or cancer antigen (CA) 125 assessable disease (Gynecologic Cancer Intergroup [GCIG] criteria) or with histologically proven diagnosis of relapse
• Disease in progression > 6 months after a first or second platinum-based line. Patients should have previously received a taxane derivative.
• ECOG performance status < 2
• Life expectancy of at least 12 weeks
• Adequate bone marrow, renal, and hepatic function

Read More

Exclusion Criteria

• Ovarian tumors of low malignant potential
• Non-epithelial ovarian or mixed epithelial/non-epithelial tumors
• Previous radiotherapy
• Prior diagnosis of malignancy
• Bowel obstruction, sub-occlusive disease, or presence of symptomatic brain metastases
• Pre-existing motor or sensory neurologic pathology or symptoms National Cancer Institute (NCI) - Common Terminology Criteria for Adverse Events (CTCAE) grade > 1
• History of congestive heart failure (New York Heart Association [NYHA] classification > 2), history of myocardial infarction within the last 6 months, or history of atrial or ventricular arrhythmias
• Severe active infection
• Severe hypersensitivity to products containing Cremophor EL and/or to compounds chemically related to paclitaxel, carboplatin or Caelyx
• Fertile women not using adequate contraceptive methods
• Pregnant or breast feeding women

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental	Pegylated liposomal doxorubicin	Caelyx-Carboplatin
Standard	Carboplatin	Paclitaxel-Carboplatin
Standard	Paclitaxel	Paclitaxel-Carboplatin
Experimental	Carboplatin	Caelyx-Carboplatin

Primary Outcome Measures

Name	Time	Method
Progression-free survival of patients in both study groups	5 years

Secondary Outcome Measures

Name	Time	Method
Qualitative and quantitative toxicities	6 months
Quality of life	6 months
Overall survival	5 years

Trial Locations

Locations (1)

Hôpital Hôtel Dieu; 🇫🇷 Paris, France