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

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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.


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.
We found this trial at
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Scarborough, ME
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