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)
- Conditions
- on Small Cell Lung CancerMedDRA version: 8.1Level: PTClassification code 10061873
- Registration Number
- EUCTR2005-005245-19-HU
- Lead Sponsor
- Bayer Pharmaceuticals Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 900
•Stage IIIB (with cytologically confirmed malignant pleural or pericardial effusion) or Stage IV histological or cytological confirmation of NSCLC
•No prior chemotherapy
•Prior local radiotherapy is allowed if it is completed at least 3 weeks prior to the first dose of study drug.
•Prior surgery is allowed if it is performed at least 4 weeks prior to the first dose of study drug.
•Age greater than or equal to 18 years old.
•ECOG Performance Status of 0 or 1
•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 start of first dose:
•Hemoglobin greater than or equal to 9.0 g/dl
•Absolute neutrophil count (ANC) greater than or equal to 1,500/mm3
•Platelet count greater than or equal to 100,000/mm3
•Total bilirubin less than or equal to 1.5 times the upper limit of normal
•ALT and AST less than or equal to 2.5 x upper limit of normal (less than or equal to 5 x upper limit of normal for patients with liver involvement)
•INR less than or equal to 1.5 and aPTT within normal limits
•Creatinine less than or equal to 1.5 times the upper limit of normal
•Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of treatment
•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.
•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
•Any prior systemic anticancer therapy including cytotoxic therapy, targeted agents, experimental therapy, adjuvant, or neo-adjuvant therapy for NSCLC
•Cardiac disease: Congestive heart failure greater than class II NYHA. 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
•Known brain metastasis. Patients with neurological symptoms should undergo at CT scan/MRI of the brain to exclude brain metastasis.
•Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
•Uncontrolled hypertension defined as systolic blood pressure greater than 150 mmHg or diastolic pressure greater than 90 mmHg, despite optimal medical management.
•Known human immunodeficiency virus (HIV) infection or chronic hepatitis B or C
•Active clinically serious infections greater than CTCAE Grade 2
•Thrombotic or embolic events such as cerebrovascular accident including transient ischemic attacks within the past 6 months
•Pulmonary hemorrhage/bleeding event greater than or equal to CTCAE Grade 2 within 4 weeks of first dose of study drug
•Any other hemorrhage/bleeding event greater than or equal to CTCAE Grade 3 within 4 weeks of first dose of study drug
•Serious, non-healing wound, ulcer, or bone fracture
•Evidence or history of bleeding diathesis or coagulopathy
•Major surgery, open biopsy or significant traumatic injury within 4 weeks of first dose of study drug
•Therapeutic anticoagulation with vitamin K antagonists such as warfarin, or with heparins or heparinoids. Low dose warfarin (1 mg po qd) is permitted if the INR is less than or equal to 1.5. Low-dose aspirin is permitted
•Use of St John’s Wort or rifampin (rifampicin)
•Known or suspected allergy to sorafenib or any agent given in the course of this trial
•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 greater than 3 years prior to study entry.
•Concurrent cancer that is distinct in primary site or histology from NSCLC
•Substance abuse, medical, psychological or social conditions that may interfere with the patient’s participation in the study or evaluation of the study results
•Any condition that impairs patient’s ability to swallow whole pills
•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