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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.
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  • 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.
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  • 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.

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 groups in NCT00780039
Study groupRoleWhat they receive
Single ArmExperimentalCaelyx 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.

  1. 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)

  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.

  1. First posted24 Oct 2008 (estimated)
  2. Study start1 Oct 2003
  3. Primary completion6 Sep 2007
  4. Study completion6 Sep 2007

Resources

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)
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 9520420

  • Power 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

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.

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