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An Open-Label Multicenter Randomized Phase 3 Study Comparing the Combination of DOXIL/CAELYX and YONDELIS With DOXIL/CAELYX Alone in Subjects With Advanced Relapsed Ovarian Cancer

Phase 3
18 Years
Not Enrolling
Ovarian Cancer

Thank you

Trial Information

An Open-Label Multicenter Randomized Phase 3 Study Comparing the Combination of DOXIL/CAELYX and YONDELIS With DOXIL/CAELYX Alone in Subjects With Advanced Relapsed Ovarian Cancer

This is a multicenter, open-label (all people know the identity of the intervention),
randomized (study medication is assigned by chance), Phase 3 study comparing the combination
of trabectedin + DOXIL with DOXIL monotherapy in patients with advanced ovarian cancer (who
were previously treated and for whom first-line platinum-based chemotherapy regimen has
failed). Approximately 650 patients will be randomly assigned to 1 of the treatment arms
(DOXIL and DOXIL + trabectedin) over 2 years. At the time of randomization, patients will be
stratified on the basis of platinum sensitivity of disease (sensitive or resistant) and
baseline Eastern Cooperative Oncology Group performance status score (0 to 1 or 2. Safety
will be evaluated on the basis of adverse events, clinical laboratory tests, physical
examination, vital signs assessment and cardiovascular safety assessment. An interim
analysis of overall survival will be performed in conjunction with progression-free survival
analysis during the study. Treatment will be continued until disease progression occurred or
until patients experienced a confirmed complete response for at least 2 cycles.
Continuation of treatment in select individual patients beyond this study end date will be
allowed if the investigator determined that the patient is benefiting from treatment, is
eligible to receive further therapy, and consents to treatment. If disease progression has
not occurred at treatment termination, then disease assessment will continue every 8 weeks
until there is evidence of disease progression or death, or until the clinical data cutoff
date, or until the start of first subsequent anticancer therapy, whichever is earlier.

Inclusion Criteria:

- Histologically proven epithelial ovarian cancer, epithelial fallopian tube cancer, or
primary peritoneal cancer

- Prior treatment with only 1 platinum based chemotherapy regimen

- Eastern Cooperative Oncology Group status of not more than 2

- Progression more than 6 months after the start of initial chemotherapy treatment

Exclusion Criteria:

- Treatment with more than 1 prior chemotherapy regimen

- Progression within 6 months after starting initial chemotherapy

- Prior exposure to anthracyclines

- Unwilling or unable to have central venous catheter

- Known clinically relevant central nervous system metastasis

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Comparing the Progression-free survival (PFS) of patients in the combination arm of trabectedin + DOXIL with DOXIL monotherapy arm

Outcome Time Frame:

Until disease progression or death

Safety Issue:


Principal Investigator

Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

Investigator Role:

Study Director

Investigator Affiliation:

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.


United States: Food and Drug Administration

Study ID:




Start Date:

April 2005

Completion Date:

November 2010

Related Keywords:

  • Ovarian Cancer
  • Ovarian cancer
  • Trabectedin
  • Yondelis
  • Advanced Relapsed Ovarian Cancer
  • Ovarian Neoplasms



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