Fallopian Tube Cancer, Ovarian Cancer, Peritoneal Neoplasms
Conditions
Keywords
Epithelial ovarian cancer, fallopian tube cancer, peritoneal cancer, primary cancer, recurrent cancer, doxorubicin, taxane chemotherapy, platinum chemotherapy, Patupilone, taxane platinum resistant
Brief summary
The objective of this study is to assess the safety and efficacy of patupilone compared to pegylated liposomal doxorubicin. Additionally, this study will assess the ability of patupilone to extend the survival time and potential beneficial effects in women who have nonresponsive or recurrent ovarian, primary fallopian, or primary peritoneal cancer.
Interventions
DRUGdoxorubicin
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years of age or older * Confirmed diagnosis of ovarian, fallopian or peritoneal cancer * No more than three chemotherapy regimens * Most recent regimen must have been platinum based
Exclusion criteria
* Have an unresolved bowel obstruction * Have had previous chemotherapy within 3 weeks * Recovering from any surgery for any cause Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To show superiority of patupilone in overall survival compared to doxorubicin in taxane/platinum resistant patients with ovarian cancer | every 8 weeks |
Secondary
| Measure | Time frame |
|---|---|
| To determine the progression-free survival (PFS) of patients treated with patupilone | end of study |
| To determine the time to disease progression (TTP) of patients treated with patupilone | end of study |
| To determine overall best tumor response (CR, PR, SD, PD and Unknown) | end of study |
| To determine the duration of overall response in patients with complete response (CR) or partial response (PR) or stable disease (SD) | End of study |
| To evaluate the pharmacokinetics (PK) of patupilone from all patients | end of study |
| To explore relationships between Cmin (pre-dose patupilone blood concentration) and efficacy/adverse events | end of study |
| To investigate the safety and tolerability of patupilone | end of study |
Countries
Australia, Canada, Denmark, Finland, France, Greece, Italy, Poland, South Africa, Spain, United Kingdom, United States
Outcome results
None listed