Epithelial Ovarian CancerNCT00538603
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)
A study testing pegylated liposomal Doxorubicin (CAELYX) & Carboplatin and Paclitaxel & Carboplatin in people with Epithelial Ovarian Cancer, run by King Faisal Specialist Hospital & Research Center.
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) Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Epithelial Ovarian Cancer
- What is being tested?
- pegylated liposomal Doxorubicin (CAELYX) & Carboplatin and Paclitaxel & Carboplatin
- How many people
- 8 participants
- Where
- No sites listed yet
- Study dates
- Jun 2005to Jun 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with epithelial Ovarian cancer in late relapse
Who cannot join
None listed.
About this study
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)
- Conditions
- Epithelial Ovarian Cancer
- Being tested
- pegylated liposomal Doxorubicin (CAELYX) & Carboplatin, Paclitaxel & Carboplatin
- Medical subject headings
- Carcinoma, Ovarian Epithelial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pegylated liposomal Doxorubicin (CAELYX) & CarboplatinDrug
Chemotherapy
Paclitaxel & CarboplatinDrug
Chemotherapy
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival
Measured: overall
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2007 (estimated)
- Study startJun 2005
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Epithelial Ovarian CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Faisal Specialist Hospital & Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Naeem A. Chaudhri, King Faisal Specialist Hospital & Research Center
- Investigators
- Adnan Munkarah, MD, Principal investigator, King Faisal Specialist Hospital & Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00538603
- Sponsor's protocol ID
- RAC #2051-062
- Status last verified
- Dec 2015
- First submitted
- 1 Oct 2007
- Last updated
- 17 Dec 2015
- Results posted
- No
Publications
Newhouse R, Nelissen E, El-Shakankery KH, Rogozinska E, Bain E, Veiga S, Morrison J. Pegylated liposomal doxorubicin for relapsed epithelial ovarian cancer. Cochrane Database Syst Rev. 2023 Jul 5;7(7):CD006910. doi: 10.1002/14651858.CD006910.pub3.
PubMed 37407274
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00538603
- Acronym / sponsor ID
- RAC #2051-062
- Conditions
- Epithelial Ovarian Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- King Faisal Specialist Hospital & Research CenterUniversity, hospital or other
- Study start
- Jun 2005
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 2 Oct 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with epithelial Ovarian cancer in late relapse
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pegylated liposomal Doxorubicin (CAELYX) & CarboplatinChemotherapy | Drug | – |
| Paclitaxel & CarboplatinChemotherapy | Drug | – |
Primary outcome
overall survival
Time frame: overall
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2015.
- Derived from this study: PubMed 37407274Newhouse R, Nelissen E, El-Shakankery KH, Rogozinska E, Bain E, Veiga S, Morrison J. Pegylated liposomal doxorubicin for relapsed epithelial ovarian cancer. Cochrane Database Syst Rev. 2023 Jul 5;7(7):CD006910. doi: 10.1002/14651858.CD006910.pub3.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adnan Munkarah, MD principal investigator
King Faisal Specialist Hospital & Research Center
Questions about this trial
What is this clinical trial studying?
A study testing pegylated liposomal Doxorubicin (CAELYX) & Carboplatin and Paclitaxel & Carboplatin in people with Epithelial Ovarian Cancer, run by King Faisal Specialist Hospital & Research Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall survival (time frame: overall). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00538603, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2015.