Approximately 75% of women with ovarian cancer present advanced disease. Survival is highly dependent on the stage of disease at the initiation of treatment. Favorable prognostic factors include young age, cell type other than clear cell or mucinous, lower stage, good performance status, small residual tumor volume after surgery, and absence of ascites. The prognosis of patients with resistant / refractory ovarian cancer is uniformly poor with median overall survival ranging from 35 – 41 weeks.
Conditions
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients MUST be started on study medication within 48 hours of randomization. Any delay beyond 48 hours must be discussed with Novartis. - Histologically confirmed diagnosis of epithelial ovarian, primary fallopian or primary peritoneal cancer. - Resistant/refractory to prior intravenous or intraperitoneal platinum-based chmotherapy (up to three prior regimens) - Taxane/platinum refractory/resistant patients must present with either measurable (by RECIST criteria) or non-measurable (CA-125 by Rustin criteria) progressive disease - Left ventricular ejection fraction (LVEF) >/= 50% by MUGA or 2-D echocardiography - Age > 18 years. - WHO performance status of 0, 1, or 2. 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Patients with CA-125-only disease - Unresolved bowel obstruction - Prior administration of epothilones, anthracyclines and/or pegylated liposomal doxorubicin - Date of first study treatment would be more than 30 days past the screening CT scan(screeningCT scan must be perforemed within 6 months from las dose of platinum based chemotherapy) confirming disease progression. - Any peripheral neuropathy > CTC grade 1 - Unresolved diarrhea of any grade within last 7 days prior to start of treatment. - Presenting with symptomaitc brain metastasis and/or leptomeningeal involvement - Within 3 weeks of receiving any prior chemotherapy or radiotherapy or who are planning to receive either while participating in the study - Severe cardiac insufficiency (NYHA III or IV), with uncontrolled and/or unstable cardiac or coronary artery disease - History of another malignancy within 5 years prior to study entry, except curatively treated non-melanotic skin cancer or cervical cancer in situ - Receiving hematopoietic growth factors (except erythropoietin) - Concomitant administration of Coumadin® or other agents containing warfarin with the exception of low dose Coumandin® (1mg or less daily) administeered prophylactically for maintenane of in-dwelling lines or ports. (Wash-out period from therapeutic dose of Coumadin should be =7 days) - Concomitant administration of any drug/agent known to cause, or increase the severity of diarrhea -Concomitant administration of any drug/agent known to interact negatively with doxorubicin or pegylated liposomal doxorubicin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To show superiority of patupilone in overall survival compared to pegylated liposomal doxorubicin (Doxil®/Caelyx®) in taxane/platinum refractory/resistant patients with recurrent epithelial ovarian, primary fallopian or primary peritoneal cancer. ;Secondary Objective: To evaluate: •progression free survival •best overall response rate according to RECIST criteria •CA-125 response for patients with evaluable disease as defined by Rustin criteria •duration of best overall response •time to progression •best overall response •the safety and tolerability of patupilone •detailed cardiac safety surveillance of a single dose of patupilone vs pegylated liposomal doxorubicin on QT interval, heart rate and cardiac conduction intervals in a limited number patients •To conduct PK-PD analysis •To perform pharmacogenomic assessments to examine whether expression levels of beta-tubulin isoforms in tumor cells correlate with resistance to patupilone. •To evaluate patient-reported symptoms and quality of life (QoL) of patients using the FACT-O. •To evaluate change in disease symptoms, as assessed by the FOSI. •To summarise the overall response by both RECIST and CA-125 as composite end-point;Primary end point(s): The primary endpoint of this study is overall survival (OS). | — |
Countries
Denmark, Finland, Greece, Hungary, Ireland, Italy, Spain, United Kingdom
Outcome results
None listed