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

Bayer246 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

246

Conditions

Ovarian Neoplasms

Interventions

Sorafenib (Nexavar, BAY43-9006)DRUG

Patients in Sorafenib arm will receive 2 Sorafenib tablets (200 mg each) twice a day and in continuous administration.

PlaceboDRUG

Patients in Placebo arm will receive 2 matching placebo tablets twice a day and in continuous administration.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (59)

Outcomes

Primary Outcomes

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.

Time frame: From randomization of the first patient until 32.5 months later, assessed every 8 weeks

Secondary Outcomes

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.

Time frame: 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).

Time frame: From randomization of the first patient until 32.5 months later

Data from ClinicalTrials.gov

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Unnamed facility

La Jolla, California, United States

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Jacksonville, Florida, United States

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Augusta, Georgia, United States

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Scarborough, Maine, United States

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Bruxelles - Brussel, Belgium

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Bruxelles - Brussel, Belgium

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Edegem, Belgium

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La Louvière, Belgium

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Leuven, Belgium

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Wilrijk, Belgium

...and 49 more locations