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Multicenter, Randomized, Non-comparative, Open-label Phase II Trial on the Efficacy and Safety of the Combination of Bevacizumab and Trabectedin With or Without Carboplatin in Adult Women With Platinum Partially Sensitive Recurring Ovarian Cancer.

Phase 2
18 Years
Not Enrolling
Ovarian Epithelial Cancer Recurrent

Thank you

Trial Information

Multicenter, Randomized, Non-comparative, Open-label Phase II Trial on the Efficacy and Safety of the Combination of Bevacizumab and Trabectedin With or Without Carboplatin in Adult Women With Platinum Partially Sensitive Recurring Ovarian Cancer.

Inclusion Criteria:

- Age≥18years

- Eastern Cooperative Oncology Group (ECOG)- performance status 0-2

- Cytological/histological diagnosis of epithelial ovarian cancer

- Progression free interval between 6-12 months (calculated from the first day of the
last cycle of the previous last platinum-based chemotherapy until the date of
progression confirmation through radiologic imaging).

- Only one previous platinum-based chemotherapy line

- Measurable disease according to RECIST version 1.1

- Life expectancy ≥ 12 weeks

- Patients must be able to receive dexamethasone or its equivalent, as a premedication
for trabectedin

- Written informed consents given before the enrolment according to International
Conference on Harmonization/ Good Clinical Practice (ICH/GCP).

Exclusion Criteria:

- Prior treatment with trabectedin

- Prior progression while on therapy containing bevacizumab or other vascular
endothelial growth factor (VEGF) pathway-target therapy

- Pre-existing grade > 1 sensitive/motor neurologic disorder

- Current or recent (within 30 days of first study dosing) treatment with another
investigational drug

- Surgery (including open biopsy) within 4 weeks prior to the first planned dose of

- Current or recent (within 10 days prior to the first study drug dose) use of
full-dose oral or parenteral anticoagulant or thrombolytic agent for therapeutic
purposes (except for line patency, in which case international normalized ratio (INR)
must be maintained below 1.5). Post operative prophylaxis with low molecular weight
heparin sc is allowed

- Inadequate bone marrow function: absolute neutrophil count (ANC): <1.5 x 109/l, or
platelet count <100 x 109/l or haemoglobin <9 g/dl. Patients may be transfused to
maintain haemoglobin values ≥9 g/dl

- Inadequate coagulation parameters: activated partial thromboplastin time (APTT) >1.5
x upper limit of normal (ULN) or INR >1.5

- Inadequate liver function, defined as: serum (total) bilirubin > ULN for the
institution AST/serum glutamic-oxaloacetic transaminase (SGOT) or ALT/ serum
glutamic-pyruvic transaminase (SGPT) >2.5 x ULN

- Inadequate renal function: serum creatinine >1.5 mg/dL or >132 micromol/L and urine
dipstick for proteinuria > or = 2+ and >1g of protein in their 24-hour urine

- History or evidence of brain metastases or spinal cord compression

- Pregnant, breastfeeding women and women of child bearing potential, who do not agree
to use a medically acceptable method of contraception through the treatment period
and for 6 months after discontinuation of treatment

- History or evidence of thrombotic or hemorrhagic disorders; including cerebrovascular
accident, stroke or transient ischemic attack or sub-arachnoid haemorrhage within 6
months prior to the first study treatment

- Uncontrolled hypertension (sustained systolic >150 mmHg and/or diastolic >100 mmHg
despite antihypertensive therapy) or clinically significant (i.e. active)
cardiovascular disease, including: myocardial infarction or unstable angina within 6
months prior to the first study treatment, New York Heart Association grade II or
greater congestive heart failure, serious cardiac arrhythmia requiring medication

- History of bowel obstruction, including subocclusive disease, related to the
underlying disease and history of abdominal fistula, gastrointestinal perforation or
intra-abdominal abscess. Evidence of recto-sigmoid involvement by pelvic examination
or bowel involvement on CT scan or clinical symptoms of bowel obstruction

- Non-healing wound, ulcer or bone fracture

- hepatitis C virus (HCV) positivity

- Other malignancy within the last 5 years, except for adequately treated carcinoma in
situ of the cervix or squamous carcinoma of the skin, or adequately controlled
limited basal cell skin cancer

Type of Study:


Study Design:

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

Outcome Measure:

Progression Free Survival at 6 months (PFS-6)

Outcome Description:

The PFS-6, defined as the percentage of patients who are alive and progression free at 6 months after the randomization.

Outcome Time Frame:

from randomization up to 6 months

Safety Issue:


Principal Investigator

Nicoletta Colombo, Medical D

Investigator Role:

Principal Investigator

Investigator Affiliation:

IRCCS Istituto Europeo di Oncologia di Milano


Italy: The Italian Medicines Agency

Study ID:




Start Date:

March 2013

Completion Date:

April 2015

Related Keywords:

  • Ovarian Epithelial Cancer Recurrent
  • ovarian cancer
  • bevacizumab
  • trabectedin
  • carboplatin
  • randomized trial
  • phase II
  • Ovarian Neoplasms
  • Neoplasms, Glandular and Epithelial