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Ovarian CancerPhase 3NCT00113607

An Efficacy and Safety Study for Yondelis (Trabectedin) in Patients With Advanced Relapsed Ovarian Cancer

A Phase 3 study testing Trabectedin, DOXIL and Dexamethasone in people with Ovarian Cancer, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. at 111 sites in 20 countries.

Completed

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

Official record
Search all trials

Trial summary

The purpose of the study is to compare the progression-free survival (PFS) of the combination of trabectedin + DOXIL with DOXIL monotherapy in patients with ovarian cancer. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Ovarian Cancer
What is being tested?
Trabectedin, DOXIL and Dexamethasone
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
672 participants
Where
111 sitesin 20 countries
Study dates
Apr 2005to Nov 2010
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Histologically proven epithelial ovarian cancer, epithelial fallopian tube cancer, or primary peritoneal cancer
  • Prior treatment with only 1 platinum based chemotherapy regimen
  • Eastern Cooperative Oncology Group status of not more than 2
  • Progression more than 6 months after the start of initial chemotherapy treatment

Who cannot join

  • Treatment with more than 1 prior chemotherapy regimen
  • Progression within 6 months after starting initial chemotherapy
  • Prior exposure to anthracyclines
  • Unwilling or unable to have central venous catheter
  • Known clinically relevant central nervous system metastasis

Trial locations and contacts

111 sites in 20 countries.

111 sites in 20 countries

United States28 sites

  • Study site

    Boston, Massachusetts

  • Study site

    Charlotte, North Carolina

  • Study site

    Chattanooga, Tennessee

  • Study site

    Cleveland, Ohio

  • Study site

    Coeur d'Alene, Idaho

  • Study site

    Dallas, Texas

  • Study site

    Englewood, Colorado

  • Study site

    Galveston, Texas

  • Study site

    Greenville, North Carolina

  • Study site

    Greenville, South Carolina

  • Study site

    Los Angeles, California

  • Study site

    Louisville, Kentucky

  • Study site

    Minneapolis, Minnesota

  • Study site

    Mobile, Alabama

  • Study site

    Morristown, New Jersey

  • Study site

    Nashville, Tennessee

  • Study site

    New Orleans, Louisiana

  • Study site

    New York, New York

  • Study site

    Newport Beach, California

  • Study site

    Orange, California

  • Study site

    Pittsburgh, Pennsylvania

  • Study site

    Portland, Oregon

  • Study site

    St Louis, Missouri

  • Study site

    Stamford, Connecticut

  • Study site

    Tampa, Florida

  • Study site

    Toledo, Ohio

  • Study site

    Tucson, Arizona

  • Study site

    Winston-Salem, North Carolina

Other trials in United States

Spain8 sites

  • Study site

    Barcelona

  • Study site

    Girona

  • Study site

    Guadalajara

  • Study site

    L'Hospitalet de Llobregat

  • Study site

    Madrid

  • Study site

    Marañón

  • Study site

    Valencia

  • Study site

    Zaragoza

Other trials in Spain

Germany7 sites

  • Study site

    Düsseldorf

  • Study site

    Heidelberg

  • Study site

    Jena

  • Study site

    Karlsruhe

  • Study site

    Mainz

  • Study site

    Villingen-Schwenningen

  • Study site

    Wilhelmshaven

Other trials in Germany

Poland7 sites

  • Study site

    Gdansku

  • Study site

    Gliwice

  • Study site

    Krakow

  • Study site

    Olsztyn

  • Study site

    Poznan

  • Study site

    Warszawa Poland

  • Study site

    Wroclaw

Other trials in Poland

United Kingdom7 sites

  • Study site

    Birmingham

  • Study site

    Edinburgh

  • Study site

    Leicester

  • Study site

    London

  • Study site

    Nottingham

  • Study site

    Poole

  • Study site

    Sheffield

Other trials in United Kingdom

Brazil6 sites

  • Study site

    Barretos

  • Study site

    Belo Horizonte

  • Study site

    Cerqueira César

  • Study site

    Londrina

  • Study site

    Santo André

  • Study site

    São Paulo

Other trials in Brazil

Russia6 sites

  • Study site

    Chelyabinsk

  • Study site

    Moscow

  • Study site

    Obninsk, Kaluga Region

  • Study site

    Orenburg

  • Study site

    Saint Petersburg

  • Study site

    Samara

Other trials in Russia

Australia5 sites

  • Study site

    Adelaide

  • Study site

    Bentleigh

  • Study site

    Douglas

  • Study site

    St Leonards

  • Study site

    Toorak Gardens

Other trials in Australia

Canada5 sites

  • Study site

    Calgary, Alberta

  • Study site

    Edmonton, Alberta

  • Study site

    Montreal, Quebec

  • Study site

    Ottawa, Ontario

  • Study site

    Québec, Quebec

Other trials in Canada

China5 sites

  • Study site

    Beijing

  • Study site

    Guangzhou

  • Study site

    Hangzhou

  • Study site

    Jinan

  • Study site

    Shanghai

Other trials in China

Belgium4 sites

  • Study site

    Edegem

  • Study site

    Hasselt

  • Study site

    Leuven

  • Study site

    Wilrijk

Other trials in Belgium

Netherlands4 sites

  • Study site

    Amsterdam

  • Study site

    Enschede

  • Study site

    Groningen

  • Study site

    Maastricht

Other trials in Netherlands

Argentina3 sites

  • Study site

    Buenos Aires

  • Study site

    Mendoza

  • Study site

    Sante Fe

Other trials in Argentina

France3 sites

  • Study site

    Chartres

  • Study site

    Paris

  • Study site

    Pierre-Bénite

Other trials in France

Hong Kong3 sites

  • Study site

    Chai Wan

  • Study site

    Hong Kong

  • Study site

    Shatin

Other trials in Hong Kong

Sweden3 sites

  • Study site

    Gothenburg

  • Study site

    Umeå

  • Study site

    Uppsala

Other trials in Sweden

Taiwan3 sites

  • Study site

    Kaohsiung County

  • Study site

    Taipei

  • Study site

    Taoyuan

Other trials in Taiwan

Chile2 sites

  • Study site

    Reneca

  • Study site

    Santiago

Other trials in Chile

Singapore1 site

  • Study site

    Singapore

Other trials in Singapore

South Korea1 site

  • Study site

    Seoul

Other trials in South Korea

About this study

Official title: An Open-Label Multicenter Randomized Phase 3 Study Comparing the Combination of DOXIL/CAELYX and YONDELIS With DOXIL/CAELYX Alone in Subjects With Advanced Relapsed Ovarian Cancer

The purpose of the study is to compare the progression-free survival (PFS) of the combination of trabectedin + DOXIL with DOXIL monotherapy in patients with ovarian cancer.

Read the detailed description

This is a multicenter, open-label (all people know the identity of the intervention), randomized (study medication is assigned by chance), Phase 3 study comparing the combination of trabectedin + DOXIL with DOXIL monotherapy in patients with advanced ovarian cancer (who were previously treated and for whom first-line platinum-based chemotherapy regimen has failed). Approximately 650 patients will be randomly assigned to 1 of the treatment arms (DOXIL and DOXIL + trabectedin) over 2 years. At the time of randomization, patients will be stratified on the basis of platinum sensitivity of disease (sensitive or resistant) and baseline Eastern Cooperative Oncology Group performance status score (0 to 1 or 2. Safety will be evaluated on the basis of adverse events, clinical laboratory tests, physical examination, vital signs assessment and cardiovascular safety assessment. An interim analysis of overall survival will be performed in conjunction with progression-free survival analysis during the study. Treatment will be continued until disease progression occurred or until patients experienced a confirmed complete response for at least 2 cycles. Continuation of treatment in select individual patients beyond this study end date will be allowed if the investigator determined that the patient is benefiting from treatment, is eligible to receive further therapy, and consents to treatment. If disease progression has not occurred at treatment termination, then disease assessment will continue every 8 weeks until there is evidence of disease progression or death, or until the clinical data cutoff date, or until the start of first subsequent anticancer therapy, whichever is earlier.

Conditions
Ovarian Cancer
Being tested
Trabectedin, DOXIL, Dexamethasone
Keywords
Ovarian cancer, Trabectedin, Yondelis, Advanced Relapsed Ovarian Cancer, DOXIL, CAELYX
Medical subject headings
Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TrabectedinDrug

    Also called Yondelis

    Type=exact number, unit=mg/m2, number=1.1, form=solution, route=IV. Trabectedin will be administered over 3 hours every 3 weeks.

  • DOXILDrug

    Also called CAELYX

    Type=exact number, unit=mg/m2, number=30, 50, form=solution, route=IV. DOXIL will be administered over 90 minutes every 4 weeks when administered alone (monotherapy) and every 3 weeks when administered with trabectedin.

  • DexamethasoneDrug

    Type=exact number, unit=mg, number=20, form=solution, route=IV. Dexamethasone or its equivalent will be administered over 30 minutes prior to the DOXIL infusion.

Study groups in NCT00113607
Study groupRoleWhat they receive
DOXIL + trabectedinExperimentalCombination arm - Trabectedin + DOXIL: DOXIL 30 mg/m2 intravenous (IV) infusion over 90 minutes + trabectedin 1.1 mg/m2 IV infusion over 3 hours every 3 weeks. patients will be premedicated with 20 mg dexamethasone or its equivalent IV infusion over 30 minutes prior to the DOXIL infusion.
Receives: Drug: Trabectedin; Drug: DOXIL; Drug: Dexamethasone
DOXILActive comparatorMonotherapy arm - DOXIL: 50 mg/m2 IV infusion over 90 minutes every 4 weeks.
Receives: Drug: DOXIL

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-Free Survival (PFS): Independent Radiologist Review

    PFS is defined as the time between randomization and disease progression or death.

    Measured: From the date of randomization until the date of disease progression or death, as assessed for approximately 3 years

Secondary outcomes (5)

  1. Overall Survival

    Overall survival was defined as the time between the randomization and death

    Measured: From the date of randomization until the date of death, as assessed for approximately 3 years

  2. Objective Response Rate (ORR) - Independent Radiologist Review

    Percentage of participants who achieved complete response (CR) or partial response (PR) as best overall response. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR) = Disappearance of all target lesions; Partial Response (PR)= greater than or equal to 30% decrease in the sum of the longest diameter of target lesions and Overall Response (OR) = CR + PR.

    Measured: From the date of randomization until the date of disease progression or death, as assessed for approximately 3 years

  3. Duration of Response: Independent Radiologist Review

    Duration of response was defined only for participants who had complete response or partial response as best overall response. Duration of response was calculated from the date of first documentation of response (not the confirmation) to the date of disease progression or death due to progressive disease.

    Measured: From the date of first documentation of response to the date of disease progression or death due to progressive disease, as assessed for approximately 3 years

  4. Median Area Under Curve (AUC) of Trabectedin.

    Median simulated area under the curve (AUC) of a 21 day trabectedin profile of participants (of this study) administering trabectedin and doxil, calculated using the trapezoidal rule method. Simulations were based on a dataset created of 1000 participants using the posthoc parameter estimations, derived from the population pharmacokinetic analysis dataset of Trabectedin (Participants=831, with resampling). Plasma concentration-time profiles were simulated up to 504 hour post-dosing using a rich sampling.

    Measured: Day 1 (Predose; 1.5 hour after start of infusion; 5 minutes, 2 hour and 6 to 20 hour after end of infusion); Day 8 (168 hour after end of infusion); and Day 15 (336 hour after end of infusion) at Cycles 1 and 2

  5. Median Maximum Plasma Concentration (Cmax) of Trabectedin.

    Median simulated maximum plasma concentration (Cmax) at 3 hour of a 21 day trabectedin profile of participants (of this study) administering trabectedin and doxil. The assessment of Cmax was based on a dataset created of 1000 participants using the posthoc parameter estimations, derived from the population pharmacokinetic analysis dataset of Trabectedin (participants=831, with resampling). Plasma concentration-time profiles were simulated up to 504 hour post-dosing using a rich sampling.

    Measured: Day 1 (Predose; 1.5 hour after start of infusion; 5 minutes, 2 hour and 6 to 20 hour after end of infusion); Day 8 (168 hour after end of infusion); and Day 15 (336 hour after end of infusion) at Cycles 1 and 2

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jun 2005 (estimated)
  2. Study startApr 2005
  3. Primary completionNov 2010
  4. Study completionNov 2010

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
672 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00113607
Sponsor's protocol ID
CR003448
Other IDs
ET743-OVA-301, 2004-005276-16, 2004
Status last verified
Jun 2014
First submitted
9 Jun 2005
Last updated
27 Jun 2014
Data monitoring committee
Yes

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

  • Jones RL, Herzog TJ, Patel SR, von Mehren M, Schuetze SM, Van Tine BA, Coleman RL, Knoblauch R, Triantos S, Hu P, Shalaby W, McGowan T, Monk BJ, Demetri GD. Cardiac safety of trabectedin monotherapy or in combination with pegylated liposomal doxorubicin in patients with sarcomas and ovarian cancer. Cancer Med. 2021 Jun;10(11):3565-3574. doi: 10.1002/cam4.3903. Epub 2021 May 7.

    PubMed 33960681

  • Krasner CN, Poveda A, Herzog TJ, Vermorken JB, Kaye SB, Nieto A, Claret PL, Park YC, Parekh T, Monk BJ. Patient-reported outcomes in relapsed ovarian cancer: results from a randomized Phase III study of trabectedin with pegylated liposomal doxorubicin (PLD) versus PLD alone. Gynecol Oncol. 2012 Oct;127(1):161-7. doi: 10.1016/j.ygyno.2012.06.034. Epub 2012 Jul 2.

    PubMed 22765965

  • Monk BJ, Herzog TJ, Kaye SB, Krasner CN, Vermorken JB, Muggia FM, Pujade-Lauraine E, Park YC, Parekh TV, Poveda AM. Trabectedin plus pegylated liposomal doxorubicin (PLD) versus PLD in recurrent ovarian cancer: overall survival analysis. Eur J Cancer. 2012 Oct;48(15):2361-8. doi: 10.1016/j.ejca.2012.04.001. Epub 2012 Apr 26.

    PubMed 22541893

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Trabectedin, DOXIL and Dexamethasone in people with Ovarian Cancer, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. at 111 sites in 20 countries.

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 4 inclusion and 5 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 27 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 111 sites in United States, Spain, Germany, Poland, United Kingdom and 15 more countries. 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?

Yes. Results are posted in the registry (first posted 23 Aug 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 (PFS): Independent Radiologist Review (time frame: From the date of randomization until the date of disease progression or death, as assessed for approximately 3 years). 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 NCT00113607, which also lists 4 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 27 Jun 2014.

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