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

Browse trials for

• Neoplasms 9,365
• Fallopian Tube Neoplasms 720
• Ovarian Neoplasms 2,695
• Peritoneal Neoplasms 361

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

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's enrollment of 581 is above the median of 50 across 7,253 interventional studies indexed under Neoplasms.

Lead sponsor

Janssen Research & Development, LLC is the lead sponsor of 912 studies on the registry; 76 are open to participants now.

Of its 278 completed or terminated interventional studies of FDA-regulated products, 131 (47%) have results posted.

Study arms

• 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.

  Drug: Trabectedin · Drug: DOXIL · Drug: Dexamethasone

• 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.

  Drug: DOXIL

Interventions

• DrugTrabectedin

  1.1 mg/m\^2 administered intravenously over approximately 3 hours on Day 1 of each 21-day treatment cycle.

• DrugDOXIL

  30 mg/m\^2 administered intravenously over approximately 90 minutes on Day 1 of each 21-day treatment cycle.

• DrugDexamethasone

  20 mg administered intravenously on Day 1 of each 21-day treatment cycle approximately 30 minutes prior to study drug infusion.

• DrugDOXIL

  50 mg/m\^2 administered intravenously over approximately 90 minutes on Day 1 of each 28-day treatment cycle.

Primary outcomes

1. Overall Survival (OS)

   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.

   Time frame: Up to 4.3 years

Secondary outcomes

1. Progression-Free Survival (PFS)

   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.

   Time frame: Up to 4.3 years

2. Objective Response Rate (ORR)

   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.

   Time frame: Up to 4.3 years

Baseline characteristics

Publications

• Jones RL, Herzog TJ, Patel SR, von Mehren M, Schuetze SM, Van Tine BA, Coleman RL, Knoblauch R, Triantos S, Hu P, Shalaby W, McGowan T, Monk BJ, Demetri GD. Cardiac safety of trabectedin monotherapy or in combination with pegylated liposomal doxorubicin in patients with sarcomas and ovarian cancer. Cancer Med. 2021 Jun;10(11):3565-3574. doi: 10.1002/cam4.3903. Epub 2021 May 7. PubMed 33960681 ↗
• Monk BJ, Herzog TJ, Wang G, Triantos S, Maul S, Knoblauch R, McGowan T, Shalaby WSW, Coleman RL. A phase 3 randomized, open-label, multicenter trial for safety and efficacy of combined trabectedin and pegylated liposomal doxorubicin therapy for recurrent ovarian cancer. Gynecol Oncol. 2020 Mar;156(3):535-544. doi: 10.1016/j.ygyno.2019.12.043. Epub 2020 Jan 8. PubMed 31924332 ↗

Study documents

• Study protocol · Jan 9, 2018
• Statistical analysis plan · Apr 12, 2018

Documents are hosted by the registry — open the source record to download them.