Phase III international, randomized study of Trabectedin plus Pegylated Liposomal Doxorubin (PLD) versus Carboplatin plus PLD in patients with ovarian cancer progressing within 6-12 months of last platinum.
- Conditions
- cancer of the ovariesovarian cancer10038594
- Registration Number
- NL-OMON40022
- Lead Sponsor
- MaNGO (Mario Negri Gynecological Oncology Group) - Instituto di Ricerche Farmacologiche 'Mario Negri'
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 60
- female older than 18 years
- patients with cancer of the ovaries, fallopian tubes or primary peritoneal cancer
- patients with 6 to 12 months PFS (progression free survival) 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 histologigal evidence of recurrent ovarian cancer , even in case of abscence of post-surgical measurable of assessable lesions
- ECOG less than or equal to 2
- life expectancy greater than or equal to 12 weeks
- adequate bone marrow, renal and liver function as defined by a number of tests (see protocol - inclusioncriteria)
- normal liver function levels
- patients are able to receive desamethasone or similar agents
- non epithelial or mixed ovarian cancer (epithelial/non-epithelial)
- patients who did not respond to the 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 larger than 1
- patients who have suffered myocardial infarction 6 months prior to enrolment (NYHA larger than or equal to 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 patient 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 cummulative doses of doxorubicin larger than 400mg/m2 or epirubicin larger than 720mg/m2
- patients treated with one of the study drugs 30 days prior to enrolment
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The pricipal research objective is to demonstrate that the combination of<br /><br>trabectedin and pegylated liposomal doxorubicin (PLD) prolongs overall survival<br /><br>(OS) over carboplatin and PLD in patients with relapsed ovarian cancer<br /><br>progressing within 6-12 months after end of last platinum based chemotherapy.<br /><br>OS will be measured from the date of randomization up to the date of death due<br /><br>to any cause or, for living patients, the date of last contact.</p><br>
- Secondary Outcome Measures
Name Time Method