Ovarian NeoplasmsPhase 2NCT00780039
A Study to Evaluate the Safety and Efficacy of Caelyx in Combination With Carboplatin in Patients With Ovarian Cancer Recurrent Within Six to Twelve Months After Initial Carboplatin and Paclitaxel Chemotherapy (P03625)
A Phase 2 study testing Pegylated Liposomal Doxorubicin and Carboplatin in people with Ovarian Neoplasms, run by Merck Sharp & Dohme LLC.
Trial summary
Doxorubicin has been used to treat ovarian cancer as part of different combination therapies, but high cumulative doses should be avoided because of the risk of cardiotoxicity. Pegylated Liposomal Doxorubicin (Caelyx) has been developed to reduce the risk of cardiotoxicity. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Neoplasms
- What is being tested?
- Pegylated Liposomal Doxorubicin and Carboplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2003to 6 Sep 2007
- Phase
- Phase 2
- 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
- Age >=18 years old
- Subject must have histological diagnosis of epithelial ovarian cancer
- Subject must have received a taxane and platinum regimen and have maintained a treatment-free status for at least six months and not more than twelve months following completion of first line therapy.
- Subject must have measurable ovarian cancer by appropriate radiological imaging.
- ECOG performance Score of 0 or 1.
- Subject's life expectancy must be > 6 months.
Show all 13Show fewer
- Subject must have normal organ function, except if abnormal due to tumor involvement:
- Adequate bone marrow function (platelets >=100 X 10^9/L, hemoglobin >=100 g/L, neutrophils >=1.5 X 10^9/L)
- Adequate renal function (serum creatinine<=1.5 X the upper limit of normal (ULN)
- Adequate liver function (bilirubin and AST or ALT<=2 times ULN, unless related to primary disease.
- MUGA scan must indicate left ventricular ejection fraction above 90%.
- Women of childbearing potential must be using adequate contraception (prescribed under medical supervision) and have a negative pregnancy test at the time of enrollment.
- Subject must be able to sign written informed consent.
Who cannot join
- Subject who is pregnant or is breast feeding.
- Subject who has history of cardiac disease, with New York Heart Association Class II or greater.
- Subject with a history of severe hypersensitivity reactions to products containing Cremophor® EL.
- Subject with clinically significant hepatic disease.
- Subject who has uncontrolled bacterial, viral, or fungal infection.
- Subject who exhibits confusion or disorientation.
Show all 9Show fewer
- Subject with any condition that would prevent adequate follow-up.
- Subject with a history of prior malignancy treated with systemic chemotherapy or radiotherapy.
- Subject who has received two or more prior chemotherapy regimens for ovarian cancer.
About this study
Official title: Phase II, Open-Label, Study of CAELYX and Carboplatin Intermediate Platinum-Sensitive (6-12 Months Treatment-free Interval) Relapsed Epithelial Ovarian Cancer.
Doxorubicin has been used to treat ovarian cancer as part of different combination therapies, but high cumulative doses should be avoided because of the risk of cardiotoxicity. Pegylated Liposomal Doxorubicin (Caelyx) has been developed to reduce the risk of cardiotoxicity. The purpose of this study is to evaluate the safety and efficacy of Caelyx in combination with carboplatin in women with recurrent ovarian cancer.
- Conditions
- Ovarian Neoplasms
- Being tested
- Pegylated Liposomal Doxorubicin, Carboplatin
- Medical subject headings
- Ovarian 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 SCH 200746
Subjects will receive Caleyx 30 mg/m2 intravenously on Day 1 of each 4-week cycle, during 6 cycles. Patients still achieving clinical benefit after a total of 6 cycles may continue therapy.
CarboplatinDrug
Subjects will receive carboplatin dosed to target AUC of 5 mg/mL.min, intravenously, on Day 1 of each 4-week cycle, after the Caelyx infusion, during 6 cycles. Patients still achieving clinical benefit after a total of 6 cycles may continue therapy.
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Experimental | Caelyx 30 mg/m2 in combination with carboplatin dosed to target AUC of 5 mg/mL.min. Receives: Drug: Pegylated Liposomal Doxorubicin; Drug: Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete response rate, according to RECIST criteria; Partial response rate, according to RECIST criteria
Measured: Complete or partial response: re-evaluation 4 weeks later to confirm response; Upon completion of chemotherapy: follow-up every 2 months until documentation of progressive disease; All patients will be followed for a minimum of one year for survival
Secondary outcomes (1)
Safety and tolerability; Duration of response; CA-125 response; Time to progression; Overall survival
Measured: All patients will be followed for a minimum of one year for survival
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2008 (estimated)
- Study start1 Oct 2003
- Primary completion6 Sep 2007
- Study completion6 Sep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Ovarian NeoplasmsStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Princess Margaret Hospital, Canada
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00780039
- Sponsor's protocol ID
- P03625
- Status last verified
- May 2017
- First submitted
- 23 Oct 2008
- Last updated
- 15 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final\_Updated%20July\_9\_2014.pdf http://engagezone.msd.com/ds\_documentation.php
Publications
Li KJ, Garoff H. Packaging of intron-containing genes into retrovirus vectors by alphavirus vectors. Proc Natl Acad Sci U S A. 1998 Mar 31;95(7):3650-4. doi: 10.1073/pnas.95.7.3650.
PubMed 9520420Power P, Stuart G, Oza A, Provencher D, Bentley JR, Miller WH Jr, Pouliot JF. Efficacy of pegylated liposomal doxorubicin (PLD) plus carboplatin in ovarian cancer patients who recur within six to twelve months: a phase II study. Gynecol Oncol. 2009 Sep;114(3):410-4. doi: 10.1016/j.ygyno.2009.04.037. Epub 2009 Jun 10.
PubMed 19520420
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II, Open-Label, Study of CAELYX and Carboplatin Intermediate Platinum-Sensitive (6-12 Months Treatment-free Interval) Relapsed Epithelial Ovarian Cancer.
- ClinicalTrials.gov ID
- NCT00780039
- Acronym / sponsor ID
- P03625
- Conditions
- Ovarian Neoplasms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Collaborators
- Princess Margaret Hospital, Canada
- Study start
- 1 Oct 2003 (actual)
- Primary completion
- 6 Sep 2007 (actual)
- Study completion
- 6 Sep 2007 (actual)
- First posted
- 24 Oct 2008 (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.
Doxorubicin has been used to treat ovarian cancer as part of different combination therapies, but high cumulative doses should be avoided because of the risk of cardiotoxicity. Pegylated Liposomal Doxorubicin (Caelyx) has been developed to reduce the risk of cardiotoxicity. The purpose of this study is to evaluate the safety and efficacy of Caelyx in combination with carboplatin in women with recurrent ovarian cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Experimental | Drug: Pegylated Liposomal Doxorubicin, Drug: CarboplatinCaelyx 30 mg/m2 in combination with carboplatin dosed to target AUC of 5 mg/mL.min. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Age >=18 years old
- Subject must have histological diagnosis of epithelial ovarian cancer
- Subject must have received a taxane and platinum regimen and have maintained a treatment-free status for at least six months and not more than twelve months following completion of first line therapy.
- Subject must have measurable ovarian cancer by appropriate radiological imaging.
- ECOG performance Score of 0 or 1.
Key exclusion criteria (9 listed)
- Subject who is pregnant or is breast feeding.
- Subject who has history of cardiac disease, with New York Heart Association Class II or greater.
- Subject with a history of severe hypersensitivity reactions to products containing Cremophor® EL.
- Subject with clinically significant hepatic disease.
- Subject who has uncontrolled bacterial, viral, or fungal infection.
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: SCH 200746Subjects will receive Caleyx 30 mg/m2 intravenously on Day 1 of each 4-week cycle, during 6 cycles. Patients still achieving clinical benefit after a total of 6 cycles may continue therapy. | Drug | Single Arm |
| CarboplatinSubjects will receive carboplatin dosed to target AUC of 5 mg/mL.min, intravenously, on Day 1 of each 4-week cycle, after the Caelyx infusion, during 6 cycles. Patients still achieving clinical benefit after a total of 6 cycles may continue therapy. | Drug | Single Arm |
Primary outcome
Complete response rate, according to RECIST criteria; Partial response rate, according to RECIST criteria
Time frame: Complete or partial response: re-evaluation 4 weeks later to confirm response; Upon completion of chemotherapy: follow-up every 2 months until documentation of progressive disease; All patients will be followed for a minimum of one year for survival
1 secondary outcome
Safety and tolerability; Duration of response; CA-125 response; Time to progression; Overall survival
Time frame: All patients will be followed for a minimum of one year for survival
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 15 May 2017.
- Results publication: PubMed 9520420Li KJ, Garoff H. Packaging of intron-containing genes into retrovirus vectors by alphavirus vectors. Proc Natl Acad Sci U S A. 1998 Mar 31;95(7):3650-4. doi: 10.1073/pnas.95.7.3650.
- Derived from this study: PubMed 19520420Power P, Stuart G, Oza A, Provencher D, Bentley JR, Miller WH Jr, Pouliot JF. Efficacy of pegylated liposomal doxorubicin (PLD) plus carboplatin in ovarian cancer patients who recur within six to twelve months: a phase II study. Gynecol Oncol. 2009 Sep;114(3):410-4. doi: 10.1016/j.ygyno.2009.04.037. Epub 2009 Jun 10.
- Individual participant dataSharing planned: Yes. http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf http://engagezone.msd.com/ds_documentation.php
Related trials for Ovarian Neoplasms
Recruiting
A Study to Compare Two Surgical Procedures in Individuals With BRCA1 Mutations to Assess Reduced Risk of Ovarian Cancer
Ovarian Carcinoma
Active, not recruitingPhase 1
A Phase 1 Study of XL309 (ISM3091) Alone and in Combination in Participants With Advanced Solid Tumors
Advanced Solid Tumor
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
Recruiting
Unravelling Tumour Biology In Ovarian Cancer With Precision Imaging
High Grade Serous Ovarian Cancer
RecruitingObservational study
Clonal Hematopoiesis and Therapy-Emergent Myeloid Neoplasms in Patients With Cancers, CHANCES Study
Recurrent Fallopian Tube Carcinoma, Recurrent Ovarian Carcinoma
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pegylated Liposomal Doxorubicin and Carboplatin in people with Ovarian Neoplasms, run by Merck Sharp & Dohme LLC.
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 13 inclusion and 9 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 15 May 2017. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Complete response rate, according to RECIST criteria; Partial response rate, according to RECIST criteria (time frame: Complete or partial response: re-evaluation 4 weeks later to confirm response; Upon completion of chemotherapy: follow-up every 2 months until documentation of progressive disease; All patients will be followed for a minimum of one year for survival). 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 NCT00780039, which also lists 2 linked publications.
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 15 May 2017; AzTrials last refreshed its copy on 7 Nov 2026.