- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00538603
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)
December 16, 2015 updated by: Dr. Naeem A. Chaudhri, King Faisal Specialist Hospital & Research Center
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
8
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients with epithelial Ovarian cancer in late relapse
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
overall survival
Time Frame: overall
|
overall
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Adnan Munkarah, MD, King Faisal Specialist Hospital & Research Centre
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2005
Primary Completion (Actual)
June 1, 2013
Study Completion (Actual)
June 1, 2013
Study Registration Dates
First Submitted
October 1, 2007
First Submitted That Met QC Criteria
October 1, 2007
First Posted (Estimate)
October 2, 2007
Study Record Updates
Last Update Posted (Estimate)
December 17, 2015
Last Update Submitted That Met QC Criteria
December 16, 2015
Last Verified
December 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Genital Neoplasms, Female
- Endocrine System Diseases
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- Endocrine Gland Neoplasms
- Ovarian Neoplasms
- Carcinoma, Ovarian Epithelial
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Antibiotics, Antineoplastic
- Carboplatin
- Paclitaxel
- Doxorubicin
- Liposomal doxorubicin
Other Study ID Numbers
- RAC #2051-062
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Epithelial Ovarian Cancer
-
City of Hope Medical CenterNational Cancer Institute (NCI)CompletedCancer Survivor | Stage IIIA Ovarian Epithelial Cancer | Stage IIIB Ovarian Epithelial Cancer | Stage IIIC Ovarian Epithelial Cancer | Stage IIA Ovarian Epithelial Cancer | Stage IIB Ovarian Epithelial Cancer | Stage IIC Ovarian Epithelial Cancer | Stage IA Ovarian Epithelial Cancer | Stage IB Ovarian... and other conditionsUnited States
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Centre Leon BerardCancer Côte d'or registry; Cancer Calvados registryUnknownOvarian Epithelial CancerFrance
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National Cancer Institute (NCI)CompletedStage IV Ovarian Epithelial Cancer | Primary Peritoneal Cavity Cancer | Recurrent Ovarian Epithelial Cancer | Stage III Ovarian Epithelial CancerUnited States
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Life Research Technologies GmbHUnknownOvarian Epithelial CancerAustria, Hungary
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National Cancer Institute (NCI)CompletedRecurrent Ovarian Epithelial Cancer | Recurrent Primary Peritoneal Cavity CancerCanada
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National Cancer Institute (NCI)CompletedStage IV Ovarian Epithelial Cancer | Primary Peritoneal Cavity Cancer | Recurrent Ovarian Epithelial Cancer | Stage III Ovarian Epithelial CancerUnited States
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City of Hope Medical CenterNational Cancer Institute (NCI)WithdrawnRecurrent Pancreatic Cancer | Stage III Pancreatic Cancer | Stage IV Pancreatic Cancer | Stage IV Ovarian Epithelial Cancer | Stage IV Ovarian Germ Cell Tumor | Recurrent Ovarian Epithelial Cancer | Recurrent Ovarian Germ Cell Tumor | Stage IIIA Ovarian Germ Cell Tumor | Stage IIIB Ovarian Germ Cell... and other conditionsUnited States
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National Cancer Institute (NCI)CompletedStage IV Ovarian Epithelial Cancer | Recurrent Ovarian Epithelial Cancer | Recurrent Primary Peritoneal Cavity Cancer | Stage IV Primary Peritoneal Cavity Cancer | Stage IIIA Ovarian Epithelial Cancer | Stage IIIB Ovarian Epithelial Cancer | Stage IIIC Ovarian Epithelial Cancer | Stage IIIA Primary... and other conditionsUnited States
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University of WashingtonNational Cancer Institute (NCI)CompletedFallopian Tube Cancer | Peritoneal Cavity Cancer | Ovarian Clear Cell Cystadenocarcinoma | Ovarian Endometrioid Adenocarcinoma | Ovarian Serous Cystadenocarcinoma | Stage IV Ovarian Epithelial Cancer | Recurrent Ovarian Epithelial Cancer | Stage III Ovarian Epithelial Cancer | Ovarian Mucinous Cystadenocarcinoma and other conditionsUnited States
Clinical Trials on pegylated liposomal Doxorubicin (CAELYX) & Carboplatin
-
Hellenic Oncology Research GroupUniversity Hospital of CreteTerminated
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EndocyteTerminated
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Spanish Breast Cancer Research GroupSchering-PloughCompleted
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Merck Sharp & Dohme LLCCompleted
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ARCAGY/ GINECO GROUPEuropean Organisation for Research and Treatment of Cancer - EORTC; Scherin... and other collaboratorsCompletedOvarian Cancer | Fallopian Tube CancerFrance
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Merck Sharp & Dohme LLCTerminated
-
University of RegensburgEssex Pharma GermanyCompleted
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Millennium Pharmaceuticals, Inc.WithdrawnOvarian CancerItaly, Switzerland
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Gynecologic Oncology GroupNational Cancer Institute (NCI)CompletedOvarian Cancer | Fallopian Tube Cancer | Primary Peritoneal Cavity Cancer
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Novo Nordisk A/SCompletedCancer | Ovarian CancerGermany, France