Ovarian CancerPhase 3CALYPSONCT00189553
Caelyx Plus Carboplatin Versus Paclitaxel Plus Carboplatin in Patients With Epithelial Ovarian Cancer in Late Relapse
A Phase 3 study testing Pegylated liposomal doxorubicin, Carboplatin and Paclitaxel in people with Ovarian Cancer and Fallopian Tube Cancer, run by ARCAGY/ GINECO GROUP at 1 site in France.
Trial summary
This is a study of the efficacy and safety of Caelyx (pegylated liposomal doxorubicin) in combination with carboplatin compared to the standard treatment of paclitaxel and carboplatin in patients with epithelial ovarian cancer in late relapse (> 6 months). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer, Fallopian Tube Cancer
- What is being tested?
- Pegylated liposomal doxorubicin, Carboplatin and Paclitaxel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 976 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2005to Jun 2012
- Phase
- Phase 3
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged > 18
- Histologically proven diagnosis of cancer of the ovary, the fallopian tube or extra-ovarian papillary serous tumors
- Measurable disease (Response Evaluation Criteria in Solid Tumor [RECIST] criteria) or cancer antigen (CA) 125 assessable disease (Gynecologic Cancer Intergroup [GCIG] criteria) or with histologically proven diagnosis of relapse
- Disease in progression > 6 months after a first or second platinum-based line. Patients should have previously received a taxane derivative.
- ECOG performance status < 2
- Life expectancy of at least 12 weeks
- Adequate bone marrow, renal, and hepatic function
Who cannot join
- Ovarian tumors of low malignant potential
- Non-epithelial ovarian or mixed epithelial/non-epithelial tumors
- Previous radiotherapy
- Prior diagnosis of malignancy
- Bowel obstruction, sub-occlusive disease, or presence of symptomatic brain metastases
- Pre-existing motor or sensory neurologic pathology or symptoms National Cancer Institute (NCI) - Common Terminology Criteria for Adverse Events (CTCAE) grade > 1
Show all 11Show fewer
- History of congestive heart failure (New York Heart Association [NYHA] classification > 2), history of myocardial infarction within the last 6 months, or history of atrial or ventricular arrhythmias
- Severe active infection
- Severe hypersensitivity to products containing Cremophor EL and/or to compounds chemically related to paclitaxel, carboplatin or Caelyx
- Fertile women not using adequate contraceptive methods
- Pregnant or breast feeding women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multi-National,Randomized, Phase III, GCIG Intergroup Study Comparing Pegylated Liposomal Doxorubicin and Carboplatin Versus Paclitaxel and Carboplatin in Patients With Epithelial Ovarian Cancer in Late Relapse (> 6 Months)
This is a study of the efficacy and safety of Caelyx (pegylated liposomal doxorubicin) in combination with carboplatin compared to the standard treatment of paclitaxel and carboplatin in patients with epithelial ovarian cancer in late relapse (> 6 months).
Read the detailed description
The main purpose of this research study is to find out if treatment of late relapse of ovarian or fallopian tube or primary peritoneal cancer with liposomal doxorubicin (Caelyx) combined with carboplatin will control the tumor growth at least as well as standard treatment of paclitaxel and carboplatin. And it is hoped that substituting paclitaxel with Caelyx in combination with carboplatin will improve the tolerance of the treatment program with at least the same efficacy and fewer side effects.
- Conditions
- Ovarian Cancer, Fallopian Tube Cancer
- Being tested
- Pegylated liposomal doxorubicin, Carboplatin, Paclitaxel
- Keywords
- Extra-ovarian papillary serous tumors, Relapse over 6 months, Previously received taxane derivative
- Medical subject headings
- Ovarian Neoplasms, Fallopian Tube Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pegylated liposomal doxorubicinDrug
Also called Caelyx
30 mg/m² every 4 weeks during 6 cycles or until progression
CarboplatinDrug
Also called generic drug
AUC 5 every 3/4 weeks during 6 cycles or until progression
PaclitaxelDrug
Also called generic drug
175 mg/m² at day 1 every 3 weeks during 6 cycles or until progression
| Study group | Role | What they receive |
|---|---|---|
| Standard | Active comparator | Paclitaxel-Carboplatin Receives: Drug: Carboplatin; Drug: Paclitaxel |
| Experimental | Experimental | Caelyx-Carboplatin Receives: Drug: Pegylated liposomal doxorubicin; Drug: Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival of patients in both study groups
Measured: 5 years
Secondary outcomes (3)
Qualitative and quantitative toxicities
Measured: 6 months
Quality of life
Measured: 6 months
Overall survival
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
- Study startApr 2005
- Primary completionJan 2009
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 976 participants (actual)
Sponsor and investigators
- Lead sponsor
- ARCAGY/ GINECO GROUP
- Sponsor type
- University, hospital or other
- Collaborators
- Schering-Plough, Arbeitsgemeinschaft Gynaekologische Onkologie Austria, AGO Study Group, Australia New Zealand Gynaecological Oncology Group, European Organisation for Research and Treatment of Cancer - EORTC, NCIC Clinical Trials Group, NSGO
- Responsible party
- Sponsor
- Investigators
- Eric Pujade-Lauraine, MD, PhD, Study chair, GINECO GROUP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00189553
- Sponsor's protocol ID
- CALYPSO
- Other IDs
- EudraCT 2004-04456-39
- Acronym
- CALYPSO
- Status last verified
- Jan 2014
- First submitted
- 12 Sep 2005
- Last updated
- 10 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-National,Randomized, Phase III, GCIG Intergroup Study Comparing Pegylated Liposomal Doxorubicin and Carboplatin Versus Paclitaxel and Carboplatin in Patients With Epithelial Ovarian Cancer in Late Relapse (> 6 Months)
- ClinicalTrials.gov ID
- NCT00189553
- Acronym / sponsor ID
- CALYPSO / CALYPSO
- Conditions
- Ovarian Cancer, Fallopian Tube Cancer
- Keywords
- Extra-ovarian papillary serous tumors, Relapse over 6 months, Previously received taxane derivative
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 976 participants (actual)
- Lead sponsor
- ARCAGY/ GINECO GROUPUniversity, hospital or other
- Collaborators
- Schering-Plough, Arbeitsgemeinschaft Gynaekologische Onkologie Austria, AGO Study Group, Australia New Zealand Gynaecological Oncology Group, European Organisation for Research and Treatment of Cancer - EORTC, NCIC Clinical Trials Group, NSGO
- Study start
- Apr 2005
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 19 Sep 2005 (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.
This is a study of the efficacy and safety of Caelyx (pegylated liposomal doxorubicin) in combination with carboplatin compared to the standard treatment of paclitaxel and carboplatin in patients with epithelial ovarian cancer in late relapse (> 6 months).
Detailed description
The main purpose of this research study is to find out if treatment of late relapse of ovarian or fallopian tube or primary peritoneal cancer with liposomal doxorubicin (Caelyx) combined with carboplatin will control the tumor growth at least as well as standard treatment of paclitaxel and carboplatin. And it is hoped that substituting paclitaxel with Caelyx in combination with carboplatin will improve the tolerance of the treatment program with at least the same efficacy and fewer side effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard | Active comparator | Drug: Carboplatin, Drug: PaclitaxelPaclitaxel-Carboplatin |
| Experimental | Experimental | Drug: Pegylated liposomal doxorubicin, Drug: CarboplatinCaelyx-Carboplatin |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients aged > 18
- Histologically proven diagnosis of cancer of the ovary, the fallopian tube or extra-ovarian papillary serous tumors
- Measurable disease (Response Evaluation Criteria in Solid Tumor [RECIST] criteria) or cancer antigen (CA) 125 assessable disease (Gynecologic Cancer Intergroup [GCIG] criteria) or with histologically proven diagnosis of relapse
- Disease in progression > 6 months after a first or second platinum-based line. Patients should have previously received a taxane derivative.
- ECOG performance status < 2
Key exclusion criteria (11 listed)
- Ovarian tumors of low malignant potential
- Non-epithelial ovarian or mixed epithelial/non-epithelial tumors
- Previous radiotherapy
- Prior diagnosis of malignancy
- Bowel obstruction, sub-occlusive disease, or presence of symptomatic brain metastases
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 doxorubicinAlso: Caelyx30 mg/m² every 4 weeks during 6 cycles or until progression | Drug | Experimental |
| CarboplatinAlso: generic drugAUC 5 every 3/4 weeks during 6 cycles or until progression | Drug | Experimental, Standard |
| PaclitaxelAlso: generic drug175 mg/m² at day 1 every 3 weeks during 6 cycles or until progression | Drug | Standard |
Primary outcome
Progression-free survival of patients in both study groups
Time frame: 5 years
3 secondary outcomes
Qualitative and quantitative toxicities
Time frame: 6 months
Quality of life
Time frame: 6 months
Overall survival
Time frame: 5 years
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 10 Jan 2014.
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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.
Eric Pujade-Lauraine, MD, PhD study chair
GINECO GROUP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Pegylated liposomal doxorubicin, Carboplatin and Paclitaxel in people with Ovarian Cancer and Fallopian Tube Cancer, run by ARCAGY/ GINECO GROUP at 1 site in France.
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 7 inclusion and 11 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 10 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Progression-free survival of patients in both study groups (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Jan 2014.