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

Last updated: March 29, 2019
Sponsor: Janssen Research & Development, LLC
Overall Status: Completed

Phase

3

Condition

Malignant Ascites

Fallopian Tube Cancer

Digestive System Neoplasms

Treatment

Trabectedin

Dexamethasone

DOXIL

Clinical Study ID

NCT01846611
CR100983
2012-004808-34
ET743OVC3006
  • Ages > 18
  • Female

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Histologically proven advanced-relapsed epithelial ovarian, primary peritoneal, orfallopian 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 ofdisease progression for >= 6 months after the last dose

  • Received second-line treatment with a platinum-based regimen, with progression ofdisease 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 asecond-line therapy are eligible if subsequent disease progression occurs >=9 monthsfrom the first dose)

  • Evidence of measurable disease at screening as evaluated by Response EvaluationCriteria in Solid Tumors (RECIST) (Version 1.1)

  • Participants no longer need to be able to receive intravenous (IV) dexamethasone or anequivalent 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 withthe 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 1according to the National Cancer Institute - Common Terminology Criteria of AdverseEvents (NCICTCAE) (Version 4.0)

  • Have a negative urine or serum pregnancy test at screening

  • Agrees to protocol-defined use of effective contraception

Exclusion

Exclusion Criteria:

  • Diagnosis of ovarian carcinoma with mucinous histology

  • Had more than 2 prior lines of systemic therapy. Maintenance therapies and hormonaltherapies are not considered additional lines of therapy

  • Participants who had a prior exposure to trabectedin or hypersensitivity to any of theexcipients will not be excluded from receiving single-agent Doxil

  • Prior treatment with doxorubicin or other anthracycline at cumulative doses greaterthan 300 mg/m2 (calculated using doxorubicin equivalent doses: 1 mg doxorubicin = 1 mgDoxil/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 beexcluded from receiving single-agent Doxil

  • Pregnant or breast-feeding

  • Would receive study treatment within 3 weeks from radiation therapy, experimentaltherapy, hormonal therapy, prior chemotherapy, or biological therapy; use an invasiveinvestigational device; or is currently enrolled in an investigational study

  • History of another invasive malignancy (except non-metastatic basal cell carcinoma orsquamous cell carcinoma of the skin or cervical carcinoma in situ adequately treated)unless in remission for >=5 years, or a non - invasive malignancy requiring ongoingtherapy

  • Known allergies, hypersensitivity, or intolerance to Doxil, dexamethasone, or theirexcipients

  • 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 hepatitisC antibodies are allowed provided they do not have active disease requiring antiviraltherapy)

  • Had a myocardial infarct within 6 months before enrollment, New York Heart Association (NYHA) Class II or greater heart failure, uncontrolled angina, severe uncontrolledventricular arrhythmias, clinically significant pericardial disease, orelectrocardiographic evidence of acute ischemic or active conduction systemabnormalities

  • Has any of the following medical conditions: uncontrolled diabetes, psychiatricdisorder (including dementia) that prevents compliance with protocol, uncontrolledseizures, newly diagnosed deep vein thrombosis, active systemic infection that islikely to interfere with study procedure or results

  • Has any condition that, in the opinion of the investigator, would compromise thewell-being of the participant or the study or prevent the participant from meeting orperforming study requirements

Study Design

Total Participants: 581
Treatment Group(s): 3
Primary Treatment: Trabectedin
Phase: 3
Study Start date:
October 16, 2013
Estimated Completion Date:
November 16, 2018

Study Description

This is a randomized (individuals assigned to study treatment by chance), open - label (identity of assigned study drug will be known), active - controlled study in adult female patients with platinum-sensitive advanced - relapsed epithelial ovarian, primary peritoneal, or fallopian tube cancer who received 2 previous lines of platinum - based chemotherapy. Approximately 670 participants will be enrolled. Patients will be stratified by 4 criteria defined in the protocol and randomly assigned in a 1:1 ratio to the trabectedin+DOXIL combination therapy group (Arm A) or to the DOXIL (pegylated liposomal doxorubicin) monotherapy group (Arm B). During the treatment phase, patients will receive study drug infusions according to 21 - day cycles in Arm A and 28 - day cycles in Arm B. Treatment will continue until the occurrence of disease progression or unacceptable treatment toxicity, or until 2 cycles after assessment of a complete response (CR). Efficacy assessments will be evaluated using Response Evaluation Criteria in Solid Tumors. Disease assessments, including assessments for patients who discontinue treatment for reasons other than disease progression, will be performed until disease progression, the start of subsequent anticancer therapy, withdrawal of consent, or the clinical cutoff date. Collection of survival status will continue until at least 514 deaths have been observed or until the clinical data cutoff date. Serial pharmacokinetic (PK) samples will be collected in a subset of patients who voluntarily consent to the PK portion of the study. Safety will be monitored throughout the study. An interim analysis of overall survival (OS) will be performed after approximately 308 participants have died. The final analysis of OS will occur when approximately 514 deaths have been observed or until the clinical cutoff date. As of Amendment 6, no new participants will be randomized to study treatment, and treatment with trabectedin should be immediately discontinued for participants assigned to Arm A (trabectedin+DOXIL). All study participants (Arm A or Arm B) currently on study 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.

Connect with a study center

  • Adelaide,
    Australia

    Site Not Available

  • Ballarat,
    Australia

    Site Not Available

  • Brisbane,
    Australia

    Site Not Available

  • Gosford,
    Australia

    Site Not Available

  • Parkville,
    Australia

    Site Not Available

  • Subiaco,
    Australia

    Site Not Available

  • Toorak Gardens,
    Australia

    Site Not Available

  • Townsville,
    Australia

    Site Not Available

  • Wodonga,
    Australia

    Site Not Available

  • Woodville,
    Australia

    Site Not Available

  • Beijing Cancer Hospital

    Beijing, 100036
    China

    Site Not Available

  • Hunan Province Cancer Hospital

    Chang Sha, 410013
    China

    Site Not Available

  • Guangzhou,
    China

    Site Not Available

  • Jinan,
    China

    Site Not Available

  • Shanghai,
    China

    Site Not Available

  • Shenyang,
    China

    Site Not Available

  • Beer Sheva,
    Israel

    Site Not Available

  • Haifa,
    Israel

    Site Not Available

  • Holon,
    Israel

    Site Not Available

  • Jerusalem,
    Israel

    Site Not Available

  • Kfar Saba,
    Israel

    Site Not Available

  • Petah Tikva,
    Israel

    Site Not Available

  • Ramat-Gan,
    Israel

    Site Not Available

  • Rehovot,
    Israel

    Site Not Available

  • Tel Aviv,
    Israel

    Site Not Available

  • Zerifin,
    Israel

    Site Not Available

  • Auckland,
    New Zealand

    Site Not Available

  • Wellington,
    New Zealand

    Site Not Available

  • Bydgoszcz,
    Poland

    Site Not Available

  • Gdańsk,
    Poland

    Site Not Available

  • Lublin,
    Poland

    Site Not Available

  • Poznan,
    Poland

    Site Not Available

  • Warszawa,
    Poland

    Site Not Available

  • Arkhangelsk,
    Russian Federation

    Site Not Available

  • Chelyabinsk,
    Russian Federation

    Site Not Available

  • Ivanovo,
    Russian Federation

    Site Not Available

  • State Medical Institution "Republican Clinical Oncological Centre" at Republic of Tatarstan

    Kazan, 420029
    Russian Federation

    Site Not Available

  • Kirov,
    Russian Federation

    Site Not Available

  • Krasnodar,
    Russian Federation

    Site Not Available

  • Moscow,
    Russian Federation

    Site Not Available

  • Moscow N/a,
    Russian Federation

    Site Not Available

  • Nalchik,
    Russian Federation

    Site Not Available

  • Nizhniy Novgorod,
    Russian Federation

    Site Not Available

  • Nizhny Novgorod,
    Russian Federation

    Site Not Available

  • FGBU Medical Radiology Research Center of Ministry of Health of RF

    Obninsk, 249020
    Russian Federation

    Site Not Available

  • Omsk,
    Russian Federation

    Site Not Available

  • Orel Oncology Dispensary

    Orel, 302020
    Russian Federation

    Site Not Available

  • Orenburg,
    Russian Federation

    Site Not Available

  • Pyatigorsk,
    Russian Federation

    Site Not Available

  • Ryazan,
    Russian Federation

    Site Not Available

  • Saint Petersburg,
    Russian Federation

    Site Not Available

  • N.N. Petrov Research Institute Of Oncology

    Saint-Petersburg, 197758
    Russian Federation

    Site Not Available

  • Saint-Petersburg,,
    Russian Federation

    Site Not Available

  • Sochi,
    Russian Federation

    Site Not Available

  • St Petersburg,
    Russian Federation

    Site Not Available

  • Ufa,
    Russian Federation

    Site Not Available

  • Yaroslavl,
    Russian Federation

    Site Not Available

  • Amanzimtoti,
    South Africa

    Site Not Available

  • Cape Town,
    South Africa

    Site Not Available

  • Durban,
    South Africa

    Site Not Available

  • Johannesburg,
    South Africa

    Site Not Available

  • Port Elizabeth,
    South Africa

    Site Not Available

  • Pretoria,
    South Africa

    Site Not Available

  • Bern,
    Switzerland

    Site Not Available

  • Luzerner Kantonsspital

    Luzern 16, 6000
    Switzerland

    Site Not Available

  • Zurich,
    Switzerland

    Site Not Available

  • Bebington,
    United Kingdom

    Site Not Available

  • Glasgow,
    United Kingdom

    Site Not Available

  • Guilford,
    United Kingdom

    Site Not Available

  • London,
    United Kingdom

    Site Not Available

  • Maidstone,
    United Kingdom

    Site Not Available

  • Manchester,
    United Kingdom

    Site Not Available

  • Plymouth,
    United Kingdom

    Site Not Available

  • Swansea,
    United Kingdom

    Site Not Available

  • Birmingham, Alabama
    United States

    Site Not Available

  • Phoenix, Arizona
    United States

    Site Not Available

  • Scottsdale, Arizona
    United States

    Site Not Available

  • Sedona, Arizona
    United States

    Site Not Available

  • Tucson, Arizona
    United States

    Site Not Available

  • Hot Springs, Arkansas
    United States

    Site Not Available

  • Greenbrae, California
    United States

    Site Not Available

  • La Jolla, California
    United States

    Site Not Available

  • Los Angeles, California
    United States

    Site Not Available

  • Orange, California
    United States

    Site Not Available

  • Sacramento, California
    United States

    Site Not Available

  • Sharpe Memorial Hospital

    San Diego, California 92103
    United States

    Site Not Available

  • Englewood, Colorado
    United States

    Site Not Available

  • New Britain, Connecticut
    United States

    Site Not Available

  • New Haven, Connecticut
    United States

    Site Not Available

  • Stamford, Connecticut
    United States

    Site Not Available

  • Fort Myers, Florida
    United States

    Site Not Available

  • Jacksonville, Florida
    United States

    Site Not Available

  • Miami, Florida
    United States

    Site Not Available

  • Saint Petersburg, Florida
    United States

    Site Not Available

  • Sarasota, Florida
    United States

    Site Not Available

  • Women's Cancer Associates

    St. Petersburg, Florida 33701
    United States

    Site Not Available

  • Tampa, Florida
    United States

    Site Not Available

  • Northeast Georgia Cancer Care, LLC

    Athens, Georgia 30607
    United States

    Site Not Available

  • Atlanta, Georgia
    United States

    Site Not Available

  • Medical College of Georgia - Augusta

    Augusta, Georgia 30912
    United States

    Site Not Available

  • Savannah, Georgia
    United States

    Site Not Available

  • Chicago, Illinois
    United States

    Site Not Available

  • Park Ridge, Illinois
    United States

    Site Not Available

  • Indianapolis, Indiana
    United States

    Site Not Available

  • Louisville, Kentucky
    United States

    Site Not Available

  • Covington, Louisiana
    United States

    Site Not Available

  • University Hospital and Clinics - Oncology at LGH

    Lafayette, Louisiana 70506
    United States

    Site Not Available

  • New Orleans, Louisiana
    United States

    Site Not Available

  • Scarborough, Maine
    United States

    Site Not Available

  • Sinai Hospital of Baltimore

    Baltimore, Maryland 21215
    United States

    Site Not Available

  • Worcester, Massachusetts
    United States

    Site Not Available

  • Detroit, Michigan
    United States

    Site Not Available

  • Lansing, Michigan
    United States

    Site Not Available

  • empty

    Coon Rapids, Minnesota
    United States

    Site Not Available

  • Duluth, Minnesota
    United States

    Site Not Available

  • Edina, Minnesota
    United States

    Site Not Available

  • Columbia, Missouri
    United States

    Site Not Available

  • Kansas City, Missouri
    United States

    Site Not Available

  • Hackensack, New Jersey
    United States

    Site Not Available

  • Morristown, New Jersey
    United States

    Site Not Available

  • New Brunswick, New Jersey
    United States

    Site Not Available

  • Summit, New Jersey
    United States

    Site Not Available

  • Island Gynecologic Oncology

    Brightwater, New York 11718
    United States

    Site Not Available

  • Brightwaters, New York
    United States

    Site Not Available

  • Hawthorne, New York
    United States

    Site Not Available

  • New York, New York
    United States

    Site Not Available

  • Alamance Regional Med Ctr

    Burlington, North Carolina 27215
    United States

    Site Not Available

  • Presbyterian Health Care

    Charlotte, North Carolina 28204
    United States

    Site Not Available

  • Pinehurst, North Carolina
    United States

    Site Not Available

  • Novant Oncology Research Institute

    Winston Salem, North Carolina 27103
    United States

    Site Not Available

  • Novant Oncology Research Institute

    Winston-Salem, North Carolina 27103
    United States

    Site Not Available

  • Akron, Ohio
    United States

    Site Not Available

  • Cincinnati, Ohio
    United States

    Site Not Available

  • University of Cincinnati Hospital

    Cincinnatti, Ohio 45267
    United States

    Site Not Available

  • Cleveland, Ohio
    United States

    Site Not Available

  • Columbus, Ohio
    United States

    Site Not Available

  • University of Toledo

    Toledo, Ohio 43614
    United States

    Site Not Available

  • Tulsa, Oklahoma
    United States

    Site Not Available

  • Portland, Oregon
    United States

    Site Not Available

  • Abington, Pennsylvania
    United States

    Site Not Available

  • Pittsburgh, Pennsylvania
    United States

    Site Not Available

  • Providence, Rhode Island
    United States

    Site Not Available

  • Charleston, South Carolina
    United States

    Site Not Available

  • Greenville, South Carolina
    United States

    Site Not Available

  • Chattanooga Gynecology Oncology

    Chattanooga, Tennessee 37403
    United States

    Site Not Available

  • Nashville, Tennessee
    United States

    Site Not Available

  • Austin, Texas
    United States

    Site Not Available

  • Bedford, Texas
    United States

    Site Not Available

  • Dallas, Texas
    United States

    Site Not Available

  • Fort Worth, Texas
    United States

    Site Not Available

  • UT MD Anderson Cancer Center

    Houstobn, Texas 77030
    United States

    Site Not Available

  • Houston, Texas
    United States

    Site Not Available

  • San Antonio, Texas
    United States

    Site Not Available

  • The Woodlands, Texas
    United States

    Site Not Available

  • Webster, Texas
    United States

    Site Not Available

  • Salt Lake City, Utah
    United States

    Site Not Available

  • Annandale, Virginia
    United States

    Site Not Available

  • Newport News, Virginia
    United States

    Site Not Available

  • Roanoke, Virginia
    United States

    Site Not Available

  • Spokane, Washington
    United States

    Site Not Available

  • Vancouver, Washington
    United States

    Site Not Available

  • Green Bay, Wisconsin
    United States

    Site Not Available

  • Madison, Wisconsin
    United States

    Site Not Available

  • Milwaukee, Wisconsin
    United States

    Site Not Available

  • Aurora West Allis Medical Center Women's Pavillion

    Wauwasota, Wisconsin 53226
    United States

    Site Not Available

  • Wauwatosa, Wisconsin
    United States

    Site Not Available

  • empty

    West Allis, Wisconsin
    United States

    Site Not Available

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