A Randomized Controlled Trial Comparing Safety and Efficacy of Carboplatin and Paclitaxel plus or minus Sorafenib BAY 43-9006 in chemonaive patients with Stage IIIB-IV Non-Small Cell Lung Cancer NSCLC - ND
- Conditions
- Treatment of Stage IIIB-IV Non-Small Cell Lung Cancer NSCLCMedDRA version: 9.1Level: LLTClassification code 10029522Term: Non-small cell lung cancer stage IV
- Registration Number
- EUCTR2005-005245-19-IT
- Lead Sponsor
- Bayer Pharmaceuticals Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 900
61623; Stage IIIB with pleural or pericardial effusion or Stage IV histological or cytological confirmation of NSCLC. 61623; No prior chemotherapy 61623; Prior local radiotherapy is allowed if it is completed at least 3 weeks prior to the first dose of study drug. 61623; Prior surgery is allowed if it is performed at least 4 weeks prior to the first dose of study drug. 61623; Age 18 years old. 61623; Eastern Cooperative Group ECOG Performance Status of 0 or 1 61623; Life expectancy of at least 12 weeks 61623; Adequate bone marrow, liver, and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to start of first dose 61623; Hemoglobin 9.0 g/dL 61623; Absolute neutrophil count 1500/mm3 61623; Platelet count 100 000/mm3 61623; Total bilirubin 1.5 times the upper limit of normal 61623; Alanine aminotransferase and aspartate aminotransferase 2.5 x upper limit of normal 5 x upper limit of normal for patients with liver involvement 61623; International Normalised Ratio 1.5 and a partial thromboplastin time within normal limits 61623; Creatinine 8804;1.5 times the upper limit of normal 61623; Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of treatment. 61623; Women of childbearing potential and men must agree to use adequate contraception barrier method of birth control prior to study entry and for the duration of study participation. Men should use adequate birth control for at least three months after the last administration of sorafenib. 61623; Ability to understand and the willingness to sign a written informed consent. A signed informed consent must be obtained prior to any study specific procedures.
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
61623; Any prior systemic anticancer therapy including cytotoxic therapy, targeted agents, experimental therapy, adjuvant, or neo-adjuvant therapy for NSCLC 61623; Cardiac disease Congestive heart failure class II New York Heart Association. Patients must not have unstable angina anginal symptoms at rest or new-onset angina began within the last 3 months or myocardial infarction within the past 6 months 61623; Known brain metastasis. Patients with neurological symptoms should undergo a computed tomography CT scan/magnetic resonance imaging MRI of the brain to exclude brain metastasis. 61623; Cardiac ventricular arrhythmias requiring antiarrhythmic therapy 61623; Uncontrolled hypertension defined as systolic blood pressure 150 mm Hg or diastolic pressure 90 mm Hg, despite optimal medical management. 61623; Known human immunodeficiency virus infection or chronic hepatitis B or C 61623; Active clinically serious infections 61502; Common Terminology Criteria for Adverse Events CTCAE Grade 2 61623; Thrombotic or embolic events such as cerebrovascular accident including transient ischemic attacks within the past 6 months 61623; Pulmonary hemorrhage/bleeding event CTCAE Grade 2 within 4 weeks of first dose of study drug 61623; Any other hemorrhage/bleeding event CTCAE Grade 3 within 4 weeks of first dose of study drug 61623; Serious, nonhealing wound, ulcer, or bone fracture 61623; Evidence or history of bleeding diathesis or coagulopathy 61623; Major surgery, open biopsy or significant traumatic injury within 4 weeks of first dose of study drug 61623; Therapeutic anticoagulation with vitamin K antagonists such as warfarin, or with heparins or heparinoids. Low-dose warfarin 1 mg orally every day is permitted if the International Normalised Ratio is 1.5. Low-dose aspirin is permitted. 61623; Use of St. John s wort or rifampin rifampicin 61623; Known or suspected allergy to sorafenib or any agent given in the course of this trial 61623; Previous cancer that is distinct in primary site or histology from NSCLC EXCEPT cervical cancer in-situ, treated basal cell carcinoma, superficial bladder tumors Ta and Tis or any cancer curatively treated 3 years prior to study entry. 61623; Concurrent cancer that is distinct in primary site or histology from NSCLC 61623; Substance abuse, medical, psychological, or social conditions that may interfere with the patient s participation in the study or evaluation of the study results 61623; Any condition that impairs patient s ability to swallow whole pills 61623; Any malabsorption condition
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