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Phase III International, Randomized Study of Trabectedin Plus Pegylated Liposomal Doxorubicin (PLD) Versus Carboplatin Plus PLD in Patients With Ovarian Cancer Progressing Within 6-12 Months of Last Platinum

Phase 3
18 Years
Not Enrolling
Ovarian Cancer

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Trial Information

Phase III International, Randomized Study of Trabectedin Plus Pegylated Liposomal Doxorubicin (PLD) Versus Carboplatin Plus PLD in Patients With Ovarian Cancer Progressing Within 6-12 Months of Last Platinum

Inclusion Criteria:

1. Female, aged ≥ 18 years

2. Histologically and/or cytologically proven epithelial ovarian, epithelial fallopian
tube cancer or primary peritoneal cancer

3. Progression free interval between six and twelve (6-12) months (calculated from the
first day of the last cycle of the last platinum-based chemotherapy until the date of
progression confirmation through radiologic imagery). Patients may have received up
to two platinum-based chemotherapy lines, of which at least one must have contained a

4. Measurable or evaluable disease confirmed by radiological imaging, such as magnetic
resonance imaging (MRI), computed tomography (CT) scan, or PET/CT scan at study entry
(CA-125 rise not supported by radiological evidence of disease is not accepted as
criteria for defining progression) or histological proven recurrent ovarian cancer
even in the absence of postoperatively measurable or evaluable lesions.

5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2

6. Estimated life expectancy ≥ 12 weeks

7. Patients must be accessible for treatment and follow-up

8. Adequate organ function within 14 days prior to first cycle as evidenced

9. Patients must be able to receive dexamethasone or its equivalent, which is required
if randomly assigned to treatment with trabectedin plus PLD

10. Informed consent of the patient

Exclusion Criteria:

1. Non epithelial ovarian or mixed epithelial/non epithelial tumors (e.g., Mullerian

2. Patients who did not respond to last platinum-based therapy or in whom last relapse
occurred < 6 months or > 12 months from the last dose of platinum

3. Bowel obstruction, sub-occlusive disease or the presence of symptomatic brain

4. Pre-existing grade > 1 motor or sensory neuropathy according to the National Cancer
Institute Common Toxicity Criteria Adverse Event (NCI-CTCAE) version 4.0

5. Myocardial infarct within six months before enrolment, New York Association (NYHA)
Class II or worse heart failure (Appendix 1. The New York Heart Association),
uncontrolled angina, severe uncontrolled ventricular arrythmias, clinically
significant pericardial disease, or electrocardiographic evidence of acute ischemic
or active conduction system abnormalities

6. History of liver disease

7. Concurrent severe medical problems or any unstable medical condition unrelated to
malignancy, which would significantly limit full compliance with the study or expose
the patient to extreme risk or decreased life expectancy

8. Breastfeeding women and women of child bearing potential must use effective
contraception during treatment and 3 months thereafter, which may include
prescription contraceptives (oral, injection, or patch), intrauterine device,
double-barrier method or male partner sterilization (not applicable to patients that
are surgically sterile)

9. Prior exposure to trabectedin

10. Prior resistance to anthracyclines or PLD defined as a progression during
anthracycline-based chemotherapy or a recurrence within 6 months from its ending

11. Prior severe PLD related toxicity

12. Prior exposure to cumulative doses of doxorubicin >400mg/m2 or epirubicin >720mg/m2

13. Treatment with any investigational product within 30 days prior to inclusion in the

Type of Study:


Study Design:

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

Outcome Measure:

Overall survival (OS)

Outcome Description:

This is an event driven study. The study will continue until 442 events have occurred.

Outcome Time Frame:

This outcome measure will be assess approximately 4.5-5 years after the last patient enrolled

Safety Issue:


Principal Investigator

Nicoletta Colombo, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

European Institute of Oncology (I.E.O), Milan, Italy


Italy: The Italian Medicines Agency

Study ID:




Start Date:

June 2011

Completion Date:

December 2017

Related Keywords:

  • Ovarian Cancer
  • Ovarian Neoplasms