Overview
Comparison of Nexavar/Placebo as Maintenance Therapy for Patients With Advanced Ovarian or Primary Peritoneal Cancer
Status:
Completed
Completed
Trial end date:
2012-12-01
2012-12-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
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.Phase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
BayerTreatments:
Niacinamide
Sorafenib
Criteria
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.