Last updated on October 2016

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

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Ovarian Cancer | Fallopian Tube Cancer | Peritoneal Cancer
  • Age: 18 Years
  • Gender: Female

Eligibility criteria:

  • Has a proven advanced-relapsed epithelial ovarian, primary peritoneal, or fallopian tube cancer
  • Has an 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)

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
  • Prior exposure to trabectedin or hypersensitivity to any of the excipients
  • Prior treatment with doxorubicin or other anthracycline at cumulative doses greater than 300 mg/m2
  • Unwilling or unable to have a central venous catheter placed
  • Pregnant or breast-feeding
  • Would receive study drug 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

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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