Clinical Trials Search
Clinical Trial 17933
Cancer Type: Gynecological Tumor
Interventions:Caelyx; Doxil (doxorubicin liposome); Yondelis (Trabectedin)
Study Type: Treatment
Phase of Study: Phase III
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
The main purpose of this study is to see if patients with epithelial ovarian, primary peritoneal, or fallopian tube cancer who were previously treated for the disease live longer if they are treated with a combination of trabectedin and DOXIL as compared to DOXIL alone. The study will also measure the safety of the trabectedin and DOXIL combination, and how well it is tolerated.
Primary objective- to compare the OS after treatment with trabectedin + DOXIL combination therapy to that observed after treatment with DOXIL monotherapy for subjects with platinum-sensitive advanced-relapsed epithelial ovarian, primary peritoneal, or fallopian tube cancer who have received 2 previous lines of platinum-based chemotherpy. Secondary objectives- to evaluate PFS, to evaluate the objective response rate (ORR), to characterize the plasma PK of trabectedin using a sparse sampling scheme in the trabectedin+DOXIL treatment group, to evaluate the safety of trabectedin+DOXIL combination therapy and DOXIL monotherapy. Exploratory objectives- to conduct pharmacogenomic evaluations of OS, PFS, and other endpoints in subjects with and without mutations in BRCA1 or BRCA2 and then evaluate patient-reported outcomes (PROs).