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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)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by King Faisal Specialist Hospital & Research Center.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Dr. Naeem A. Chaudhri, King Faisal Specialist Hospital & Research Center
ClinicalTrials.gov Identifier:
NCT00538603
First received: October 1, 2007
Last updated: April 16, 2012
Last verified: April 2012
  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: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by King Faisal Specialist Hospital & Research Center:

Primary Outcome Measures:
  • overall survival [ Time Frame: overall ] [ Designated as safety issue: No ]

Estimated Enrollment: 8
Study Start Date: June 2005
Estimated Study Completion Date: June 2013
Estimated 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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with epithelial Ovarian cancer in late relapse
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00538603

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

No publications provided

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
Study First Received: October 1, 2007
Last Updated: April 16, 2012
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on November 24, 2014