Patupilone Versus Doxorubicin in Patients With Ovarian, Primary Fallopian, or Peritoneal Cancer

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized, Parallel Group, Open-label, Active Controlled, Multicenter Phase III Trial of Patupilone (EPO906) Versus Pegylated Liposomal Doxorubicin in Taxane/Platinum Refractory/Resistant Patients With Recurrent Epithelial Ovarian, Primary Fallopian or Primary Peritoneal Cancer

Conditions
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Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Neoplasms

Intervention / Treatment
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* Drug: EPO906 (Patupilone)
* Drug: doxorubicin


Participation Criteria
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Eligibility Criteria
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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/exclusion criteria will apply.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patupilone<br> | Drug: EPO906 (Patupilone)<br> <br> * Other names: Patupilone;|
| Active Comparator: doxorubicin<br> | Drug: doxorubicin<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 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 investigate the safety and tolerability of patupilone |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Epithelial ovarian cancer, fallopian tube cancer, peritoneal cancer, primary cancer, recurrent cancer, doxorubicin, taxane chemotherapy, platinum chemotherapy, Patupilone, taxane platinum resistant