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
Condition: Ovarian Neoplasms; Peritoneal Neoplasms; Fallopian Tube Neoplasms
MeSH terms: Neoplasms; Fallopian Tube Neoplasms; Ovarian Neoplasms; Peritoneal Neoplasms
Intervention: Trabectedin; DOXIL; Dexamethasone; DOXIL
Intervention description: 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.; 50 mg/m^2 administered intravenously over approximately 90 minutes on Day 1 of each 28-day treatment cycle.
Intervention MeSH terms: Dexamethasone; Liposomal doxorubicin; Doxorubicin; Trabectedin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 581.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Ovarian neoplasms; Peritoneal neoplasms; Fallopian tube neoplasms; Advanced-relapsed epithelial ovarian cancer; Advanced-relapsed primary peritoneal cancer; Advanced-relapsed fallopian tube cancer; Trabectedin; Yondelis; Doxil; Caelyx; Platinum sensitive; Tthird-line; BRCA; Patient related outcome

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 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