A Study Comparing the Combination of Trabectedin (YONDELIS) and DOXIL/CAELYX With DOXIL/CAELYX for the Treatment of Advanced-Relapsed Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
A Randomized, Open-Label Study Comparing the Combination of YONDELIS and DOXIL/CAELYX With DOXIL/CAELYX Monotherapy for the Treatment of Advanced-Relapsed Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
3 other identifiers
interventional
581
10 countries
138
Brief Summary
The purpose of this study is to assess the efficacy and safety of trabectedin+DOXIL as a third-line chemotherapy regimen (treatment) in patients with platinum-sensitive advanced-relapsed epithelial ovarian, primary peritoneal, or fallopian tube cancer who received 2 previous lines of platinum-based chemotherapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Oct 2013
Longer than P75 for phase_3
138 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 1, 2013
CompletedFirst Posted
Study publicly available on registry
May 3, 2013
CompletedStudy Start
First participant enrolled
October 16, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 18, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
November 16, 2018
CompletedResults Posted
Study results publicly available
February 6, 2019
CompletedApril 1, 2019
March 1, 2019
4.3 years
May 1, 2013
January 17, 2019
March 29, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Survival (OS)
OS is defined as the time between the date of randomization and the date of death. Participants who died, regardless of the cause of death, were considered to have had an event.
Up to 4.3 years
Secondary Outcomes (2)
Progression-Free Survival (PFS)
Up to 4.3 years
Objective Response Rate (ORR)
Up to 4.3 years
Study Arms (2)
Arm A: trabectedin + DOXIL
EXPERIMENTALParticipants will receive DOXIL 30 millgram per meter square (mg/m\^2) administered as an intravenous (IV) infusion over approximately 90 minutes followed by trabectedin 1.1 mg/m\^2 administered as an IV infusion over approximately 3hours, every 3 weeks. Participants will be pretreated with 20 mg dexamethasone IV (or the IV equivalent) approximately 30 minutes before DOXIL study drug. As of Amendment 6, treatment with trabectedin will be discontinued for participants on treatment with trabectedin and no new participants will receive trabectedin. Participants who, in the opinion of the investigator, are deriving clinical benefit may continue treatment with single-agent DOXIL as per the local standard of care.
Arm B: DOXIL
ACTIVE COMPARATORParticipants will receive DOXIL, 50 mg/m\^2 administered as an IV infusion over approximately 90 minutes every 4 weeks.
Interventions
1.1 mg/m\^2 administered intravenously over approximately 3 hours on Day 1 of each 21-day treatment cycle.
30 mg/m\^2 administered intravenously over approximately 90 minutes on Day 1 of each 21-day treatment cycle.
20 mg administered intravenously on Day 1 of each 21-day treatment cycle approximately 30 minutes prior to study drug infusion.
Eligibility Criteria
You may qualify if:
- Histologically proven advanced-relapsed epithelial ovarian, primary peritoneal, or fallopian tube cancer
- Eastern Cooperative Oncology Group (ECOG) performance status grade of 0 or 1
- Received first-line treatment with a platinum-based regimen and had no evidence of disease progression for \>= 6 months after the last dose
- Received second-line treatment with a platinum-based regimen, with progression of disease after attaining a response
- Progression of disease based on imaging after the second-line platinum-based regimen (individuals treated with a pegylated liposomal doxorubicin-containing regimen as a second-line therapy are eligible if subsequent disease progression occurs \>=9 months from the first dose)
- Evidence of measurable disease at screening as evaluated by Response Evaluation Criteria in Solid Tumors (RECIST) (Version 1.1)
- Participants no longer need to be able to receive intravenous (IV) dexamethasone or an equivalent IV corticosteroid
- Have a known BRCA 1/2 mutation status (for participants who do not have a known BRCA 1/2 status at screening, a blood sample will be collected to determine the status with the results available prior to randomization
- Laboratory values within protocol -defined parameters
- Have left ventricular ejection fraction by multigated acquisition scan (MUGA) scan or 2D-ECHO within normal limits for the institution
- Have side effects (except alopecia) of prior treatment resolved to at least Grade 1 according to the National Cancer Institute - Common Terminology Criteria of Adverse Events (NCICTCAE) (Version 4.0)
- Have a negative urine or serum pregnancy test at screening
- Agrees to protocol-defined use of effective contraception
You may not qualify if:
- Diagnosis of ovarian carcinoma with mucinous histology
- Had more than 2 prior lines of systemic therapy. Maintenance therapies and hormonal therapies are not considered additional lines of therapy
- Participants who had a prior exposure to trabectedin or hypersensitivity to any of the excipients will not be excluded from receiving single-agent Doxil
- Prior treatment with doxorubicin or other anthracycline at cumulative doses greater than 300 mg/m2 (calculated using doxorubicin equivalent doses: 1 mg doxorubicin = 1 mg Doxil/Caelyx = 1.8 mg epirubicin = 0.3 mg mitoxantrone = 0.25 mg idarubicin)
- Participants unwilling or unable to have a central venous catheter placed will not be excluded from receiving single-agent Doxil
- Pregnant or breast-feeding
- Would receive study treatment within 3 weeks from radiation therapy, experimental therapy, hormonal therapy, prior chemotherapy, or biological therapy; use an invasive investigational device; or is currently enrolled in an investigational study
- History of another invasive malignancy (except non-metastatic basal cell carcinoma or squamous cell carcinoma of the skin or cervical carcinoma in situ adequately treated) unless in remission for \>=5 years, or a non - invasive malignancy requiring ongoing therapy
- Known allergies, hypersensitivity, or intolerance to Doxil, dexamethasone, or their excipients
- Known history of central nervous system metastasis
- Known significant chronic liver disease, such as cirrhosis or active hepatitis (potential participants who test positive for hepatitis B surface antigen or hepatitis C antibodies are allowed provided they do not have active disease requiring antiviral therapy)
- Had a myocardial infarct within 6 months before enrollment, New York Heart Association (NYHA) Class II or greater heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, clinically significant pericardial disease, or electrocardiographic evidence of acute ischemic or active conduction system abnormalities
- Has any of the following medical conditions: uncontrolled diabetes, psychiatric disorder (including dementia) that prevents compliance with protocol, uncontrolled seizures, newly diagnosed deep vein thrombosis, active systemic infection that is likely to interfere with study procedure or results
- Has any condition that, in the opinion of the investigator, would compromise the well-being of the participant or the study or prevent the participant from meeting or performing study requirements
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Janssen Research & Development, LLClead
- PharmaMarcollaborator
Study Sites (138)
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Birmingham, Alabama, United States
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Phoenix, Arizona, United States
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Scottsdale, Arizona, United States
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Sedona, Arizona, United States
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Tucson, Arizona, United States
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Hot Springs, Arkansas, United States
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Greenbrae, California, United States
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La Jolla, California, United States
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Los Angeles, California, United States
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Orange, California, United States
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Sacramento, California, United States
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Englewood, Colorado, United States
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New Britain, Connecticut, United States
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New Haven, Connecticut, United States
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Stamford, Connecticut, United States
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Fort Myers, Florida, United States
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Jacksonville, Florida, United States
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Miami, Florida, United States
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Sarasota, Florida, United States
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St. Petersburg, Florida, United States
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Tampa, Florida, United States
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Atlanta, Georgia, United States
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Savannah, Georgia, United States
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Chicago, Illinois, United States
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Park Ridge, Illinois, United States
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Indianapolis, Indiana, United States
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Louisville, Kentucky, United States
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Covington, Louisiana, United States
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New Orleans, Louisiana, United States
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Scarborough, Maine, United States
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Worcester, Massachusetts, United States
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Detroit, Michigan, United States
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Lansing, Michigan, United States
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Duluth, Minnesota, United States
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Edina, Minnesota, United States
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Columbia, Missouri, United States
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Kansas City, Missouri, United States
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Hackensack, New Jersey, United States
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Morristown, New Jersey, United States
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New Brunswick, New Jersey, United States
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Summit, New Jersey, United States
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Brightwaters, New York, United States
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Hawthorne, New York, United States
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New York, New York, United States
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Pinehurst, North Carolina, United States
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Akron, Ohio, United States
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Cincinnati, Ohio, United States
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Cleveland, Ohio, United States
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Columbus, Ohio, United States
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Tulsa, Oklahoma, United States
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Portland, Oregon, United States
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Abington, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Providence, Rhode Island, United States
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Charleston, South Carolina, United States
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Greenville, South Carolina, United States
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Nashville, Tennessee, United States
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Austin, Texas, United States
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Bedford, Texas, United States
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Dallas, Texas, United States
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Fort Worth, Texas, United States
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Houston, Texas, United States
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San Antonio, Texas, United States
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The Woodlands, Texas, United States
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Webster, Texas, United States
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Salt Lake City, Utah, United States
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Annandale, Virginia, United States
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Newport News, Virginia, United States
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Roanoke, Virginia, United States
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Spokane, Washington, United States
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Vancouver, Washington, United States
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Green Bay, Wisconsin, United States
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Madison, Wisconsin, United States
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Milwaukee, Wisconsin, United States
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Wauwatosa, Wisconsin, United States
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Adelaide, Australia
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Ballarat, Australia
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Brisbane, Australia
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Gosford, Australia
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Parkville, Australia
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Subiaco, Australia
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Toorak Gardens, Australia
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Townsville, Australia
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Wodonga, Australia
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Woodville, Australia
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Guangzhou, China
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Jinan, China
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Shanghai, China
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Shenyang, China
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Beersheba, Israel
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Haifa, Israel
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Holon, Israel
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Jerusalem, Israel
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Kfar Saba, Israel
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Petah Tikva, Israel
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Ramat Gan, Israel
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Rehovot, Israel
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Tel Aviv, Israel
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Ẕerifin, Israel
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Auckland, New Zealand
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Wellington, New Zealand
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Bydgoszcz, Poland
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Gdansk, Poland
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Lublin, Poland
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Poznan, Poland
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Warsaw, Poland
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Arkhangelsk, Russia
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Chelyabinsk, Russia
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Ivanovo, Russia
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Kirov, Russia
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Krasnodar, Russia
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Moscow, Russia
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Nal'chik, Russia
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Nizhny Novgorod, Russia
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Omsk, Russia
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Orenburg, Russia
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Pyatigorsk, Russia
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Ryazan, Russia
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Saint Petersburg, Russia
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Sochi, Russia
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Ufa, Russia
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Yaroslavl, Russia
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Cape Town, South Africa
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Durban, South Africa
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eManzimtoti, South Africa
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Johannesburg, South Africa
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Port Elizabeth, South Africa
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Pretoria, South Africa
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Bern, Switzerland
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Zurich, Switzerland
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Bebington, United Kingdom
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Glasgow, United Kingdom
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Guildford, United Kingdom
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London, United Kingdom
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Maidstone, United Kingdom
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Manchester, United Kingdom
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Plymouth, United Kingdom
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Swansea, United Kingdom
Related Publications (3)
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.
PMID: 37407274DERIVEDJones 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.
PMID: 33960681DERIVEDMonk BJ, Herzog TJ, Wang G, Triantos S, Maul S, Knoblauch R, McGowan T, Shalaby WSW, Coleman RL. A phase 3 randomized, open-label, multicenter trial for safety and efficacy of combined trabectedin and pegylated liposomal doxorubicin therapy for recurrent ovarian cancer. Gynecol Oncol. 2020 Mar;156(3):535-544. doi: 10.1016/j.ygyno.2019.12.043. Epub 2020 Jan 8.
PMID: 31924332DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Senior Medical Director
- Organization
- Janssen Research & Development, LLC
Study Officials
- STUDY DIRECTOR
Janssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 1, 2013
First Posted
May 3, 2013
Study Start
October 16, 2013
Primary Completion
January 18, 2018
Study Completion
November 16, 2018
Last Updated
April 1, 2019
Results First Posted
February 6, 2019
Record last verified: 2019-03