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
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01846611|
Recruitment Status : Completed
First Posted : May 3, 2013
Results First Posted : February 6, 2019
Last Update Posted : April 1, 2019
|Condition or disease||Intervention/treatment||Phase|
|Ovarian Neoplasms Peritoneal Neoplasms Fallopian Tube Neoplasms||Drug: Trabectedin Drug: DOXIL Drug: Dexamethasone||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||581 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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 Fallopian Tube Cancer|
|Actual Study Start Date :||October 16, 2013|
|Actual Primary Completion Date :||January 18, 2018|
|Actual Study Completion Date :||November 16, 2018|
Experimental: Arm A: trabectedin + DOXIL
Participants will receive DOXIL 30 millgram per meter square (mg/m^2) administered as an intravenous (IV) infusion over approximately 90 minutes followed by trabectedin 1.1 mg/m^2 administered as an IV infusion over approximately 3hours, every 3 weeks. Participants will be pretreated with 20 mg dexamethasone IV (or the IV equivalent) approximately 30 minutes before DOXIL study drug. As of Amendment 6, treatment with trabectedin will be discontinued for participants on treatment with trabectedin and no new participants will receive trabectedin. Participants 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.
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.
Active Comparator: Arm B: DOXIL
Participants will receive DOXIL, 50 mg/m^2 administered as an IV infusion over approximately 90 minutes every 4 weeks.
50 mg/m^2 administered intravenously over approximately 90 minutes on Day 1 of each 28-day treatment cycle.
- Overall Survival (OS) [ Time Frame: Up to 4.3 years ]OS is defined as the time between the date of randomization and the date of death. Participants who died, regardless of the cause of death, were considered to have had an event.
- Progression-Free Survival (PFS) [ Time Frame: Up to 4.3 years ]PFS is defined as the time between the date of randomization and the date of disease progression or death. PFS was assessed using the response evaluation criteria in solid tumors (RECIST) Version 1.1. As per criteria progressive disease in case of target lesions means at least a 20 percent (%) increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeter (mm). Progressive disease in case of non-target lesions means unequivocal progression of existing non-target lesions. In both cases the appearance of one or more new lesions is also considered progression.
- Objective Response Rate (ORR) [ Time Frame: Up to 4.3 years ]ORR is defined as the percentage of participants with measurable disease achieving a best overall response of either complete response (CR) or partial response (PR) based on RECIST. CR: disappearance of all target and non-target lesions and normalization of tumor marker levels in non-target lesions. PR: at least a 30 percent (%) decrease in the sum of longest diameter (LD) of target lesions or persistence of one or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01846611
|Study Director:||Janssen Research & Development, LLC Clinical Trial||Janssen Research & Development, LLC|