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

Phase 2

Completed

• Conditions: Ovarian Neoplasms
• Interventions: Drug: Sorafenib (Nexavar, BAY43-9006); Drug: Placebo

• Registration Number: NCT00791778
• Lead Sponsor: Bayer

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2008-11
• Study First Submitted: 2008-11-14
• Study First Submitted QC: 2008-11-14
• Study First Posted: 2008-11-17
• Primary Completion: 2011-07
• Results First Submitted: 2012-11-01
• Results First Submitted QC: 2012-11-01
• Results First Posted: 2012-11-30
• Study Completion: 2012-12
• Status Verified: 2015-06
• Last Update Submitted: 2015-08-26
• Last Update Posted: 2015-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 246

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.

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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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sorafenib (Nexavar, BAY43-9006)	Sorafenib (Nexavar, BAY43-9006)	Participants received 2 sorafenib tablets (200 mg each) per oral twice daily (bid)
Placebo	Placebo	Participants received 2 matching placebo tablets per oral twice daily

Primary Outcome Measures

Name	Time	Method
Progression-free Survival (PFS), Based on Radiological or Pathologic Assessment	From randomization of the first patient until 32.5 months later, assessed every 8 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Time to First Pathologic CA-125 (Cancer-associated Tumor Marker) Serum Level	From randomization of the first patient until 32.5 months later, assessed every 8 weeks	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.
Overall Survival (OS)	From randomization of the first patient until 32.5 months later	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).