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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)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00538603
First Posted: October 2, 2007
Last Update Posted: December 17, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Dr. Naeem A. Chaudhri, King Faisal Specialist Hospital & Research Center
  Purpose
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)

Condition Intervention
Epithelial Ovarian Cancer Drug: pegylated liposomal Doxorubicin (CAELYX) & Carboplatin Drug: Paclitaxel & Carboplatin

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Dr. Naeem A. Chaudhri, King Faisal Specialist Hospital & Research Center:

Primary Outcome Measures:
  • overall survival [ Time Frame: overall ]

Enrollment: 8
Study Start Date: June 2005
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: pegylated liposomal Doxorubicin (CAELYX) & Carboplatin
    Chemotherapy
    Drug: Paclitaxel & Carboplatin
    Chemotherapy
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with epithelial Ovarian cancer in late relapse
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00538603


Sponsors and Collaborators
King Faisal Specialist Hospital & Research Center
Investigators
Principal Investigator: Adnan Munkarah, MD King Faisal Specialist Hospital & Research Centre
  More Information

Responsible Party: Dr. Naeem A. Chaudhri, Principal Investigator, King Faisal Specialist Hospital & Research Center
ClinicalTrials.gov Identifier: NCT00538603     History of Changes
Other Study ID Numbers: RAC #2051-062
First Submitted: October 1, 2007
First Posted: October 2, 2007
Last Update Posted: December 17, 2015
Last Verified: December 2015

Additional relevant MeSH terms:
Ovarian Neoplasms
Neoplasms, Glandular and Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Neoplasms by Histologic Type
Paclitaxel
Liposomal doxorubicin
Albumin-Bound Paclitaxel
Carboplatin
Doxorubicin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors