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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: 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 Fa

Brief 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.

Detailed Summary: 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. 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.
Sponsor: Janssen Research & Development, LLC

Current Primary Outcome: Overall survival [ Time Frame: Up to 2 months after the last participant has received the last dose of study medication or when 514 deaths have been observed, whichever is later ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Progression free survival [ Time Frame: Up to the date of disease progression or death measured up to 2 months after the last participant has received the last dose of study medication or when 514 deaths have been ]
  • Objective response rate [ Time Frame: Up to 2 months after the last participant has received the last dose of study medication or when 514 deaths have been observed, whichever is later ]
  • Area under the concentration curve of trabectedin as derived from sparse population pharmacokinetics [ Time Frame: Predose Day 1, 1 hour after start of study dose infusion, 10 minutes before the end of study dose infusion, and 0.5, 24, and 168 hours after the end of study dose infusion on Cycle 1 only ]
  • Minimum observed plasma concentration of trabectedin as derived from sparse population pharmacokinetics [ Time Frame: Predose Day 1, 1 hour after start of study dose infusion, 10 minutes before the end of study dose infusion, and 0.5, 24, and 168 hours after the end of study dose infusion on Cycle 1 only ]
  • Maximum observed plasma concentration of trabectedin as derived from sparse population pharmacokinetics [ Time Frame: Predose Day 1, 1 hour after start of study dose infusion, 10 minutes before the end of study dose infusion, and 0.5, 24, and 168 hours after the end of study dose infusion on Cycle 1 only ]
  • Number of participants affected by an adverse event [ Time Frame: Up to 30 days after the last participant has received the last dose of study medication ]


Original Secondary Outcome: Same as current

Information By: Janssen Research & Development, LLC

Dates:
Date Received: May 1, 2013
Date Started: October 16, 2013
Date Completion: December 16, 2019
Last Updated: May 4, 2017
Last Verified: May 2017