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NCT00538603 Clinical Trial

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 Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00538603
Other study ID # RAC #2051-062
Secondary ID
Status Completed
Phase N/A
First received October 1, 2007
Last updated December 16, 2015
Start date June 2005
Est. completion date June 2013

Study information
Verified date December 2015
Source King Faisal Specialist Hospital & Research Center
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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)

Recruitment information / eligibility
Status Completed
Enrollment 8
Est. completion date June 2013
Est. primary completion date June 2013
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- Patients with epithelial Ovarian cancer in late relapse

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• pegylated liposomal Doxorubicin (CAELYX) & Carboplatin
Chemotherapy
• Paclitaxel & Carboplatin
Chemotherapy

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
King Faisal Specialist Hospital & Research Center

Outcome
Type Measure Description Time frame Safety issue
Primary overall survival overall No
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