Comparison of Nexavar/Placebo as Maintenance Therapy for Patients With Advanced Ovarian or Primary Peritoneal Cancer
Status: | Completed |
---|---|
Conditions: | Ovarian Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/21/2016 |
Start Date: | November 2008 |
End Date: | December 2012 |
A Double-Blind, Randomized Phase II Study Evaluating the Efficacy and Safety of Sorafenib Compared to Placebo in Ovarian Epithelial Cancer or Primary Peritoneal Cancer Patients Who Have Achieved a Complete Clinical Response After Standard Platinum/Taxane Containing Chemotherapy
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.
Ovarian or primary Peritoneal cancers in complete remission following surgery and one
regimen of chemotherapy.
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.
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