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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 is ongoing, but not recruiting participants.
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
History of Changes
  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:

U.S. FDA Resources

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
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:
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
 Doxorubicin
Carboplatin
Paclitaxel
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on May 19, 2013