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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Ovarian Neoplasms

Intervention / Treatment
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* Drug: Sorafenib (Nexavar, BAY43-9006)
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sorafenib (Nexavar, BAY43-9006)<br>Participants received 2 sorafenib tablets (200 mg each) per oral twice daily (bid) | Drug: Sorafenib (Nexavar, BAY43-9006)<br>* Patients in Sorafenib arm will receive 2 Sorafenib tablets (200 mg each) twice a day and in continuous administration.<br>|
| Placebo Comparator: Placebo<br>Participants received 2 matching placebo tablets per oral twice daily | Drug: Placebo<br>* Patients in Placebo arm will receive 2 matching placebo tablets twice a day and in continuous administration.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free Survival (PFS), Based on Radiological or Pathologic Assessment | Time from randomization to the first documented disease progression by radiological or pathologic assessment or death due to any cause whichever occurred first. For patients who had not progressed or died at the time of analysis, PFS was censored at the date of their last evaluable tumor scan. | From randomization of the first patient until 32.5 months later, assessed every 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to First Pathologic CA-125 (Cancer-associated Tumor Marker) Serum Level | Time from randomization to the first documented increase of CA-125 above the upper limit of normal. Patients without pathologic CA-125 increase at the time of analysis were censored at their last date of evaluation of CA-125. | From randomization of the first patient until 32.5 months later, assessed every 8 weeks | 
| Overall Survival (OS) | The OS time was measured from the date of randomization until the date of death due to any cause. Patients who were alive at the time of analysis were censored at the date of the last contact (last time the patient was known to be alive). | From randomization of the first patient until 32.5 months later | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Peritoneal Neoplasma