EUCTR2008-004429-41-ES
Active, not recruiting
Phase 1
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)
Bayer Healthcare AG, D-51368 Leverkusen, Germany0 sites0 target enrollmentNovember 25, 2008
Conditionsa 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
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- 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.
- Sponsor
- Bayer Healthcare AG, D-51368 Leverkusen, Germany
- Status
- Active, not recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
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.
Outcomes
Primary Outcomes
Not specified
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