A randomized, parallel group, open-label, active controlled, multicenter Phase III trial of Patupilone (EPO906) versus pegylated liposomal doxorubicin (Doxil/Caelyx) in taxane/platinum refractory/resistant patients with recurrent epithelial ovarian, primary fallopian or primary peritoneal cancer
- Conditions
- Approximately 75% of women with ovarian cancer present advanced disease. Survival is highly dependent on the stage of disease at the initiation of treatment. Recommended first-line therapy is a combination of platinum drug and paclitaxel. Patients who progress during primary therapy or within 6 months after are considered platinum refractory/resistant. The prognosis of patients with resistant / refractory ovarian cancer is uniformly poor with median overall survival ranging from 35 – 41 weeks
- Registration Number
- EUCTR2004-005181-20-GR
- Lead Sponsor
- ovartis Pharma Services AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 0
- Histologically confirmed diagnosis of epithelial ovarian, primary fallopian or primary peritoneal cancer.
- No more than one prior intravenously administered taxane/platinum-based combination chemotherapy regimen of at least the initial platinum dose of carboplatin AUC 5-6 or cisplatin 75mg/m2
- 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
- Patients with CA-125-only disease
- Unresolved bowel obstruction
- Prior administration of and/or known hypersensitivity to: epothilones, anthracyclines and/or pegylated liposomal doxorubicin
- Any peripheral neuropathy > CTC grade 1
- Unresolved diarrhea of any grade within last 7 days prior to start of treatment.
- Presenting with 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
- 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
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