Sorafenib in Treating Non-Smokers or Former Light Smokers With Relapsed or Refractory Stage IIIB or Stage IV Non-Small Cell Lung Cancer

• Status: Terminated
• Trial end date: 2012-04-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.

PURPOSE: This phase II trial is studying how well sorafenib works in treating non-smokers or former light smokers with relapsed or refractory stage IIIB or stage IV non-small cell lung cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ohio State University Comprehensive Cancer Center
• Collaborator: Bayer
• Treatments: Niacinamide; Sorafenib

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed non-small cell lung cancer

• Stage IIIB or IV disease

• Recurrent disease after prior surgery, chemotherapy, or radiotherapy

• No squamous cell histology or mixed tumor with > 50% squamous cells

• Non-smoker (smoked ≤ 100 cigarettes in lifetime) OR former light smoker (smoked > 100 cigarettes but ≤ 10 pack years AND quit smoking ≥ 1 year ago)

• No known brain metastasis

• Patients with neurological symptoms must undergo a CT scan or MRI of the brain to exclude brain metastasis

PATIENT CHARACTERISTICS:

• ECOG(Eastern Cooperative Oncology Group)performance status 0-2

• ANC (Absolute Neutrophil Count)≥ 1,500/mm³

• Platelet count ≥ 100,000/mm³

• ALT (Alanine Aminotransferase Test) and AST (Aspartate Aminotransferase Test) ≤ 2.5 times upper limit of normal (ULN)

• Alkaline phosphatase ≤ 2.5 times ULN

• Bilirubin ≤ 1.5 mg/dL

• Creatinine clearance ≥ 50 mL/min

• INR (International Normalized Ratio) < 1.5 OR PT/PTT (Prothrombin time/partial thromboplastin time)normal

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective barrier contraception prior to, during, and for ≥ 3 months after completion of study treatment

• No cardiac disease, including any of the following:

• New York Heart Association class III-IV congestive heart failure

• Unstable angina (anginal symptoms at rest)

• New-onset angina within the past 3 months

• Myocardial infarction within the past 6 months

• No cardiac ventricular arrhythmias requiring anti-arrhythmic therapy

• No uncontrolled hypertension (i.e., systolic blood pressure [BP] > 150 mm Hg or diastolic BP > 90 mm Hg) despite optimal medical management

• No thrombolic or embolic events (e.g., cerebrovascular accident, including transient ischemic attacks) within the past 6 months

• No pulmonary hemorrhage or bleeding event ≥ CTCAE (Common Terminology Criteria for Adverse Events)grade 2 within the past 4 weeks

• No other hemorrhage or bleeding event ≥ CTCAE grade 3 within the past 4 weeks

• No active clinically serious infection > CTCAE grade 2

• No serious non-healing wound, ulcer, or bone fracture

• No evidence or history of bleeding diathesis or coagulopathy

• No known HIV infection or chronic hepatitis B or C

• No other malignancy except for any of the following:

• Adequately treated basal cell or squamous cell skin cancer

• In situ cervical cancer

• Other cancer from which the patient has been disease-free for ≥ 5 years with a low probability of recurrence

• No condition that impairs the patient's ability to swallow whole pills

• No malabsorption problems

• No known or suspected allergy to sorafenib tosylate or any agent given in the course of this study

• No significant traumatic injury within the past 4 weeks

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• No more than one prior systemic chemotherapy treatment for metastatic disease

• Prior treatment with EGFR inhibitors is not considered chemotherapy

• More than 4 weeks since prior major surgery or open biopsy

• No prior sorafenib tosylate

• No concurrent St. John's wort or rifampin

• Concurrent anticoagulation with warfarin or heparin allowed