Estudio de fase II, aleatorizado, doble ciego, para evaluar la eficacia y la seguridad de sorafenib comparado con placebo en pacientes con cáncer epitelial de ovario o con cáncer peritoneal primario que han alcanzado una respuesta clínica completa después de quimioterapia estándar con platino/taxano. (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
- a población del estudio incluirá a pacientes con cáncer de ovario en estadío III o IV de la FIGO o cáncer peritoneal primario que se hayan sometido a cirugía de citorreducción amplia y que hayan alcanzado una respuesta completa clínica (desaparición de todos los signos clínicos y radiológicos del tumor) después de un régimen de quimioterapia estándar con platino/taxano para los que se considere médicamente aceptable el tratamiento con sorafenib.MedDRA version: 9.1 Level: LLT Classification code 10033163 Term: Ovarian epithelial cancer stage IIIMedDRA version: 9.1 Level: LLT Classification code 10033164 Term: Ovarian epithelial cancer stage IVMedDRA version: 9.1 Level: LLT Classification code 10052171 Term: Peritoneal carcinomaMedDRA version: 9.1 Level: PT Classification code 10052171 Term: Peritoneal carcinoma
- Registration Number
- EUCTR2008-004429-41-ES
- Lead Sponsor
- Bayer Healthcare AG, D-51368 Leverkusen, Germany
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
- 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
- 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
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method