cancer of the ovaries ovarian cancer
Conditions
Interventions
For this study there are two treatment groups, one study treatment group and
one control treatment group.
The patients in treatment group A will receive 30 mg/m2 PLD as a one hour
intravenous infusi
Sponsors
MaNGO (Mario Negri Gynecological Oncology Group) - Instituto di Ricerche Farmacologiche 'Mario Negri'
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - 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
Exclusion criteria
Exclusion criteria: - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The pricipal research objective is to demonstrate that the combination of trabectedin and pegylated liposomal doxorubicin (PLD) prolongs overall survival (OS) over carboplatin and PLD in patients with relapsed ovarian cancer progressing within 6-12 months after end of last platinum based chemotherapy. OS will be measured from the date of randomization up to the date of death due to any cause or, for living patients, the date of last contact. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary objectives are: - to evaluate the time from randomization to subsequent chemotherapy and the overall survival counted from the administration of subsequent chemotherapy - to evaluate serological response of CA-125 in each arm - to compare the quality of life (QoL) in each arm using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-30 (QLQ-30) and the Quality of Life Questionnaire-OV28 (QLQ-OV28) - to compare safety profile, progression free survival (PFS), objective repsonse rate (ORR), the type and lenght of remission (response rate and PFS) after subsequent therapies following each of the two combinations - sub-study in selected centers to perform pharmacokinetic (PK) analyses in both plasma and ascites in a subset of patients receiving trabectedin and PLD. The substudy will not be run in the Netherlands. The secondary outcome measures are: 1) Efficacy: - PFS: will be measured from the date of randomization to the date of documented disease progression (DP) or death (regardless of cause of death). All patients should have documented DP before the administration of subsequent anitcancer therapy although if a patient receives further antitumor therapy before DP, PFS will be censored on the date of administration of this antitumor therapy For the determination of PFS, the following events will be taken into account: - death due to any cause - radiological tumor progression by RECIST v1.1 - objective clinical progression (such as progressive peritoneal carcinomatosis with increasing bowel dysfunction, increased ascites requiring palliative drainage, emerging surgical procedure due to bowel obstruction) - objective response rate: will be the best response obtained in any evaluation according to RECIST v1.1 - CA-125 serological response: will be the best response obtained in each arm - duration of response: will be calculated from the date of first documentation of response ( | — |
Countries
Netherlands
Outcome results
None listed