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-DK
- Lead Sponsor
- ovartis Pharma Services AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 810
- Histologically confirmed diagnosis of epithelial ovarian, primary fallopian or primary peritoneal cancer.
- Resistant / refractory to prior intravenous or intraperitoneal platinum-based chemotherapy (up to three prior regimens)
- Taxane/platinum refractory/resistant patients must present with either measurable (by RECIST criteria) or non-measurable (based on both imaging and CA-125 evaluations) 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.
- Negative serum pregnancy test at screening (Not applicable to patients who are surgically sterilized or who are postmenopausal).
- Sexually active female patients must either be surgically sterilized, post-menopausal (no regular menstrual bleeding for at least 2 years) or practicing an acceptable form of birth control (i.e. double barrier method – intrauterine device plus condom, spermicidal gel plus condom)
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 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 performed within 6 months from last 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 symptomatic 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 Coumadin® (1 mg or less daily) administered prophylactically for maintenance 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
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