A Phase III international, randomized study with Trabectedin and Pegylated Liposomal Doxorubicin (PLD) compared to chemotherapy with Carboplatin and PLD in patients with ovarian cancer which reappeared within 6-12 months after the last platinum-based chemotherapy.
- Conditions
- Ovarian cancerMedDRA version: 17.1Level: LLTClassification code 10033130Term: Ovarian cancer NOSSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2010-022949-17-AT
- Lead Sponsor
- Mario Negri Gynecology Oncology Group - MaNGO
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 600
- Women age >18
- Patients with cancer of the ovaries, fallopian tubes or primary peritoneal cancer.
- Patients with 6 to 12 months PFS from the date of their last platinum-based treatment cycle to radiologically
confirmed progression. Patients may have received more than 2 platinum-based treatment lines; at least one of which
must have contained taxanes.
- Measurable or assessable disease, radiologically confirmed by tests such as MRI, CT scan or PET/CT (CA-125
alone is not acceptable) or histological evidence of recurrent ovarian cancer, even in case of absence of post-surgical
measurable or assessable lesions.
- ECOG = 2
- Life expectancy = 12 weeks
- Patients willing to commit to treatment and follow-ups.
- Adequate bone marrow, renal and liver function as defined by the following tests (to be carried out 14 days prior to
starting 1st treatment cycle):
i. Haemoglobin = 9g/dl
ii. Neutrophils = 1,5 x 109/L
iii. Platelets = 100 x 109/L
iv. Glomerular filtration rate calculated using Cockroft-Gault formula > 60 ml/min
v. Creatine phosphokinase (CPK) = 2.5 x ULN
vi. Total Bilirubin = ULN
vii. Total alkaline phosphatase = 2.5 x ULN
viii. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 2.5 x ULN
- Normal liver function levels
- Patients able to receive desametasone or similar agents
- Written informed consent provided by the patient prior to randomization
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 420
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 180
- Non epithelial or mixed ovarian cancer (Epithelial/non epithelial)
- Patients who did not respond to last platinum-based treatment or patients who have experienced progression after
less than 6 months or after more than 12 months from last dose of platinum-based treatment.
- Intestinal occlusion or subocclusion or symptomatic brain metastasis
- Pre-existing sensitive/motor neurological disorder, NCI-CTCAE degree > 1
- Patients who have suffered myocardial infarction 6 months prior to enrolment (NYHA = 2), angina pectoris, severe
ventricular arrhythmia, clinically significant pericardial disease or acute ischemic disease confirmed by ECG.
- History of liver disease
- Severe comorbidities that are not cancer related and which would significantly limit full compliance to protocol, or
that would put patients at risk or limit their life expectancy.
- Pregnant or nursing women; women of childbearing age must use adequate contraception.
- Patients previously exposed to Trabectedin
- Resistance to treatment with anthracycline or PLD, i.e. progression within 6 months of completing treatment with
these agents.
- Patients with demonstrated severe PLD related toxicity.
- Previous exposure to cumulative doses of doxorubicin > 400mg/m2 or epirubicin > 720 mg/m2
- Patients treated with one of the study drugs 30 days prior to enrolment.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method