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: The study population will include patients with FIGO stage III or IV ovarian cancer or primary peritoneal cancer who have had extensive debulkment surgery and who have achieved a clinical complete response (disappearance of all clinical and radiological evidence of tumor) after one regimen of standard platinum/taxane-based chemotherapy for whom treatment with sorafenib is considered medically acceptable.; MedDRA version: 9.1Level: LLTClassification code 10033163Term: Ovarian epithelial cancer stage III; MedDRA version: 9.1Level: LLTClassification code 10033164Term: Ovarian epithelial cancer stage IV; MedDRA version: 9.1Level: LLTClassification code 10052171Term: Peritoneal carcinoma; MedDRA version: 9.1Level: PTClassification code 10052171Term: Peritoneal carcinoma

• Registration Number: EUCTR2008-004429-41-DE
• Lead Sponsor: Bayer Healthcare AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01-12
• Last Update Posted: 9 December 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 250

Inclusion Criteria

• Patients must be able and willing to sign a written informed consent. A signed informed consent must be appropriately obtained prior to any study specific procedures.
• Age =18 years.
• Histologically confirmed FIGO stage 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. No previous chemotherapy can be administered except for the one regimen for ovarian or primary peritoneal cancer.
• Normal serum CA125 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.
• Life expectancy of at least 12 weeks.
• Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to screening:
- Hemoglobin =8.5 g/dl
- Absolute neutrophil count (ANC) =1,500/mm3
- Platelet count = 75,000/µl
- Total bilirubin = 1.5 times the upper limit of normal
- Alanine transaminase (ALT) and Aspartate aminotransferase (AST) = 2.5 x upper limit of normal
- Alkaline phosphatase = 4 x upper limit of normal (ULN)
- Prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) < 1.5 x ULN
- Serum creatinine = 1.5 x ULN.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• Patients with any residual cancer tissue after the completion of chemotherapy detectable by standard CT or magnetic resonance imaging (MRI).
• Prior local radiotherapy, neoadjuvant chemotherapy or intraperitoneal chemotherapy for any current or prior diagnosis of ovarian or primary peritoneal cancer.
• 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.
• Non-healing wound, ulcer, or bone fracture.
• Evidence or history of bleeding diathesis or coagulopathy.
• Clinically significant cardiac disease including congestive heart failure > class II New York Heart Association (NYHA), unstable angina (angina symptoms at rest), new-onset angina (begun within the last 3 months) or myocardial infarction within the past 6 months prior to randomization.
• Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy or uncontrolled hypertension (systolic blood pressure > 150 mmHg or diastolic pressure > 90 mmHg) despite optimal medical management.
• Thrombotic or embolic venous or arterial events, such as a cerebrovascular accident, including transient ischemic attacks and pulmonary embolism within the past 6 months.
• Hemorrhage/bleeding event = NCI-Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 within 30 days of randomization.
• Infection > NCI-CTCAE Grade 2.
• Known human immunodeficiency virus infection or infection with hepatitis B or C.
• Previous or concurrent cancer that is distinct in primary site or histology from ovarian or primary peritoneal cancer within 5 years prior to randomization EXCEPT cervical cancer in situ, treated basal cell carcinoma and superficial bladder tumors [Ta (Non invasive tumor), Tis (Carcinoma in situ) and T1 (Tumor invades lamina propria)].
• Known or suspected allergy to sorafenib or hypersensitivity to sorafenib or any agent given in the course of this trial.
• Patients with seizure disorder requiring medication (such as steroids or anti-epileptics).
• Patients undergoing renal dialysis.
• Substance abuse, medical, psychological or social conditions that may interfere with the patient’s participation in the study or evaluation of the study results.
• Unresolved toxicity (i.e. neurotoxicity) attributed to the required chemotherapy higher than NCI-CTCAE (version 3) Grade 2 (excluding cases of alopecia).
• Patients unable to swallow oral medications.
• Any malabsorption condition.
• Any condition that is unstable or could jeopardize the safety of the patient and their compliance in the study.
• Known brain metastasis. Patients with unexplained neurological symptoms will undergo a CT scan/MRI of the brain to exclude brain metastasis.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified