Ovarian Cancer Clinical Trial
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
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.
Full 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.
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
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There is 1 Location for this study
Birmingham Alabama, , United States
Phoenix Arizona, , United States
Scottsdale Arizona, , United States
Sedona Arizona, , United States
Tucson Arizona, , United States
Hot Springs Arkansas, , United States
Greenbrae California, , United States
La Jolla California, , United States
Los Angeles California, , United States
Orange California, , United States
Sacramento California, , United States
Englewood Colorado, , United States
New Britain Connecticut, , United States
New Haven Connecticut, , United States
Stamford Connecticut, , United States
Fort Myers Florida, , United States
Jacksonville Florida, , United States
Miami Florida, , United States
Saint Petersburg Florida, , United States
Sarasota Florida, , United States
Tampa Florida, , United States
Atlanta Georgia, , United States
Savannah Georgia, , United States
Chicago Illinois, , United States
Park Ridge Illinois, , United States
Indianapolis Indiana, , United States
Louisville Kentucky, , United States
Covington Louisiana, , United States
New Orleans Louisiana, , United States
Scarborough Maine, , United States
Worcester Massachusetts, , United States
Detroit Michigan, , United States
Lansing Michigan, , United States
Duluth Minnesota, , United States
Edina Minnesota, , United States
Columbia Missouri, , United States
Kansas City Missouri, , United States
Hackensack New Jersey, , United States
Morristown New Jersey, , United States
New Brunswick New Jersey, , United States
Summit New Jersey, , United States
Brightwaters New York, , United States
Hawthorne New York, , United States
New York New York, , United States
Pinehurst North Carolina, , United States
Akron Ohio, , United States
Cincinnati Ohio, , United States
Cleveland Ohio, , United States
Columbus Ohio, , United States
Tulsa Oklahoma, , United States
Portland Oregon, , United States
Abington Pennsylvania, , United States
Pittsburgh Pennsylvania, , United States
Providence Rhode Island, , United States
Charleston South Carolina, , United States
Greenville South Carolina, , United States
Nashville Tennessee, , United States
Austin Texas, , United States
Bedford Texas, , United States
Dallas Texas, , United States
Fort Worth Texas, , United States
Houston Texas, , United States
San Antonio Texas, , United States
The Woodlands Texas, , United States
Webster Texas, , United States
Salt Lake City Utah, , United States
Annandale Virginia, , United States
Newport News Virginia, , United States
Roanoke Virginia, , United States
Spokane Washington, , United States
Vancouver Washington, , United States
Green Bay Wisconsin, , United States
Madison Wisconsin, , United States
Milwaukee Wisconsin, , United States
Wauwatosa Wisconsin, , United States
Adelaide , , Australia
Ballarat , , Australia
Brisbane , , Australia
Gosford , , Australia
Parkville , , Australia
Subiaco , , Australia
Toorak Gardens , , Australia
Townsville , , Australia
Wodonga , , Australia
Woodville , , Australia
Guangzhou , , China
Jinan , , China
Shanghai , , China
Shenyang , , China
Beer Sheva , , Israel
Haifa , , Israel
Holon , , Israel
Jerusalem , , Israel
Kfar Saba , , Israel
Petah Tikva , , Israel
Ramat-Gan , , Israel
Rehovot , , Israel
Tel Aviv , , Israel
Zerifin , , Israel
Auckland , , New Zealand
Wellington , , New Zealand
Bydgoszcz , , Poland
Gdańsk , , Poland
Lublin , , Poland
Poznan , , Poland
Warszawa , , Poland
Arkhangelsk , , Russian Federation
Chelyabinsk , , Russian Federation
Ivanovo , , Russian Federation
Kirov , , Russian Federation
Krasnodar , , Russian Federation
Moscow N/a , , Russian Federation
Moscow , , Russian Federation
Nalchik , , Russian Federation
Nizhniy Novgorod , , Russian Federation
Nizhny Novgorod , , Russian Federation
Omsk , , Russian Federation
Orenburg , , Russian Federation
Pyatigorsk , , Russian Federation
Ryazan , , Russian Federation
Saint Petersburg , , Russian Federation
Saint-Petersburg, , , Russian Federation
Sochi , , Russian Federation
St Petersburg , , Russian Federation
Ufa , , Russian Federation
Yaroslavl , , Russian Federation
Amanzimtoti , , South Africa
Cape Town , , South Africa
Durban , , South Africa
Johannesburg , , South Africa
Port Elizabeth , , South Africa
Pretoria , , South Africa
Bern , , Switzerland
Zurich , , Switzerland
Bebington , , United Kingdom
Glasgow , , United Kingdom
Guilford , , United Kingdom
London , , United Kingdom
Maidstone , , United Kingdom
Manchester , , United Kingdom
Plymouth , , United Kingdom
Swansea , , United Kingdom
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