Comparison of Nexavar/Placebo as Maintenance Therapy for Patients With Advanced Ovarian or Primary Peritoneal Cancer

Bayer

Status and phase

Completed

Phase 2

Conditions

Ovarian Neoplasms

Treatments

Drug: Placebo

Drug: Sorafenib (Nexavar, BAY43-9006)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00791778

2008-004429-41 (EudraCT Number)

12007

Details and patient eligibility

About

Comparison of Nexavar with a placebo as maintenance therapy for patients with advanced Ovarian or primary Peritoneal cancers in complete remission following surgery and one regimen of chemotherapy.

Enrollment

246 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Histologically confirmed International Federation of Gynecology and Obstetrics (FIGO) stage (67) III or IV ovarian epithelial cancer or primary peritoneal cancer at presentation. Patients must have achieved a clinical complete response (disappearance of all clinical and radiological evidence of tumor) after only one regimen (4-6 cycles) of platinum and taxane-based standard chemotherapy received after tumor debulkment.
Normal serum CA125 (cancer-associated tumor marker) level within 7 days of first dose of sorafenib.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
All scans used to document complete response must be done within 30 days prior to randomization.
Patients must be able to swallow and retain oral medication.

Exclusion criteria

Patients with any residual cancer tissue after the completion of chemotherapy detectable by standard Computed tomography (CT) or magnetic resonance imaging (MRI).
Prior local radiotherapy, neoadjuvant chemotherapy or intraperitoneal chemotherapy.
Histologic subtypes of ovarian cancer other than epithelial (i.e. sarcoma, lymphoma, germ cell).
Major surgery, open biopsy, or significant traumatic injury within 30 days prior to randomization.