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)Bay 43-9006 / 11961
- Conditions
- on-Small Cell Lung CancerNon-Small Cell Lung CancerCancer - Lung - Non small cell
- Registration Number
- ACTRN12606000316505
- Lead Sponsor
- Bayer Australia Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Stopped early
- Sex
- All
- Target Recruitment
- 926
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. Performance status (Eastern Cooperative Group) of 0 or 1. Life expectancy of at least 12 weeks.Adequate bone marrow, liver and renal function.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.
Any prior systemic anticancer therapy including cytotoxic therapy, targeted agents, experimental therapy, adjuvant, or neo-adjuvant therapy for NSCLC.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 Known brain metastasis. Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy. Uncontrolled hypertension. Known human immunodeficiency virus (HIV) infection or chronic hepatitis B or C. Active clinically serious infections. Thrombotic or embolic events such as cerebrovascular accident including transient ischemic attacks within the past 6 months. Pulmonary hemorrhage/bleeding event within 4 weeks of first dose of study drug. Any other hemorrhage/bleeding event 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.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 or any cancer curatively treated less 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
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary efficacy objective is to compare overall survival (OS) in patients treated with carboplatin, paclitaxel and sorafenib to OS in patients treated with carboplatin, paclitaxel and placebo.[The outcome is measured after up to 6 cylces (21 day cycles) of treatment.]
- Secondary Outcome Measures
Name Time Method Secondary objectives include tumor response, duration of response, progression free survival and patient reported outcomes.[The secondary outcomes are measured after up to 6 cylces (21 day cycles) of treatment.]