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

Novartis

Status and phase: Completed; Phase 3

Conditions: Peritoneal Neoplasms; Fallopian Tube Cancer; Ovarian Cancer

Treatments: Drug: doxorubicin; Drug: EPO906 (Patupilone)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00262990

CEPO906A2303

Details and patient eligibility

About

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.

Enrollment: 829 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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829 participants in 2 patient groups

Patupilone

Experimental group

Treatment:

Drug: EPO906 (Patupilone)

doxorubicin

Active Comparator group

Treatment:

Drug: doxorubicin