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Multi-national, Randomized, Phase III, GCIG Intergroup Study Comparing Pegylated Liposomal Doxorubicin (CAELYX) and Carboplatin vs. Paclitaxel and Carboplatin in Patients With Epithelial Ovarian Cancer in Late Relapse. (CALYPSO)

Epithelial Ovarian Cancer

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

pegylated liposomal Doxorubicin (CAELYX) & Carboplatin

Paclitaxel & Carboplatin

Sponsored by

1. Study Identification

Unique Protocol Identification Number

NCT00538603

Brief Title

Multi-national, Randomized, Phase III, GCIG Intergroup Study Comparing Pegylated Liposomal Doxorubicin (CAELYX) and Carboplatin vs. Paclitaxel and Carboplatin in Patients With Epithelial Ovarian Cancer in Late Relapse. (CALYPSO)

Official Title

Multi-national, Randomized, Phase III, GCIG Intergroup Study Comparing Pegylated Liposomal Doxorubicin (CAELYX) and Carboplatin vs. Paclitaxel and Carboplatin in Patients With Epithelial Ovarian Cancer in Late Relapse. (CALYPSO)

Study Type

Interventional

2. Study Status

Record Verification Date

December 2015

Overall Recruitment Status

Completed

Study Start Date

June 2005 (undefined)

Primary Completion Date

June 2013 (Actual)

Study Completion Date

June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

King Faisal Specialist Hospital & Research Center

4. Oversight

5. Study Description

Brief Summary

Multi-national, randomized, phase III, GCIG Intergroup study comparing pegylated liposomal Doxorubicin (CAELYX) and Carboplatin vs. Paclitaxel and Carboplatin in patients with epithelial ovarian cancer in late relapse. (CALYPSO)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Epithelial Ovarian Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

8 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

pegylated liposomal Doxorubicin (CAELYX) & Carboplatin

Intervention Description

Chemotherapy

Intervention Type

Drug

Intervention Name(s)

Paclitaxel & Carboplatin

Intervention Description

Chemotherapy

Primary Outcome Measure Information:

Title

overall survival

Time Frame

overall

10. Eligibility

Sex

All

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: Patients with epithelial Ovarian cancer in late relapse

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Adnan Munkarah, MD

Organizational Affiliation

King Faisal Specialist Hospital & Research Centre

Official's Role

Principal Investigator

12. IPD Sharing Statement