Sorafenib and High-Dose Carboplatin, Paclitaxel, and External-Beam Radiation Therapy in Treating Patients With Stage III Non-Small Cell Lung Cancer

This is an interventional treatment trial for Lung Cancer focused on measuring stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer, recurrent non-small cell lung cancer, adenocarcinoma of the lung, squamous cell lung cancer, large cell lung cancer, bronchoalveolar cell lung cancer, adenosquamous cell lung cancer Read More

DISEASE CHARACTERISTICS:

Inclusion criteria:

• Histologically or cytologically documented non-small cell lung cancer (NSCLC)

  • Any of the following subtypes allowed:

    • Adenocarcinoma (including bronchoalveolar cell)
    • Squamous cell carcinoma
    • Large cell anaplastic carcinoma (including giant and clear cell carcinomas)
    • Poorly differentiated (not otherwise specified) NSCLC
  • No metastasis (patients must be M0)
  • Stage IIIA (T1 or T2 with N2 or T3N1-2) or stage IIIB (T4 with any N or any T with N2 or N3) disease
• Measurable disease

• Tumors adjacent to a vertebral body are allowed as long as all gross disease can be encompassed in the radiation boost field

  • The boost volume must be limited to < 50% of the ipsilateral lung volume

• Pleural effusion that is a transudate, cytologically negative, and nonbloody allowed if the radiation oncologists feel the tumor can still be encompassed within a reasonable field of radiotherapy

  • Pleural effusions seen on the chest CT but too small to tap allowed

Exclusion criteria:

• Totally resected tumors
• Exudative, bloody, or cytologically malignant effusions

• Known brain metastasis

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

PATIENT CHARACTERISTICS:

Inclusion criteria:

• Zubrod performance status 0-1
• ANC ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³
• Hemoglobin ≥ 9 g/dL (prior to transfusions)
• Total bilirubin ≤ 1.5 mg/dL
• AST or ALT ≤ 3 times upper limit of normal (ULN)
• Alkaline phosphatase ≤ 2.5 times ULN
• Glucose ≤ 2 times ULN
• Creatinine ≤ 2.0 mg/dL
• FEV_1 ≥ 1,200 mL
• Weight loss ≤ 10% over the past 3 months
• Not pregnant or nursing
• Negative pregnancy test
• Women of childbearing potential and male participants who are unwilling or unable to use an acceptable method of contraception throughout the study and for 4 weeks after completion of treatment or those who are using a prohibited contraceptive method
• INR < 1.5 or a PT/PTT within normal limits

Exclusion criteria:

• Known allergy to murine proteins or Cremophor EL
• Active pulmonary infection not responsive to conventional antibiotics
• History of severe chronic obstructive pulmonary disease requiring ≥ 3 hospitalizations over the past year

• Cardiac disease including any of the following:

  • Congestive heart failure > class II NYHA
  • Unstable angina (anginal symptoms at rest) or new onset angina (began within the last 3 months)
  • Myocardial infarction within the past 6 months
  • Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
• Patients with neuropathy > grade 1
• Evidence of malignancy in the past 2 years except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other in situ cancer
• Uncontrolled hypertension defined as systolic blood pressure > 150 mm Hg or diastolic pressure > 90 mm Hg, despite optimal medical management
• Known HIV infection or chronic hepatitis B
• Active clinically serious infection > CTCAE grade 2
• Thrombolic or embolic events, such as a cerebrovascular accident including transient ischemic attacks, within the past 6 months
• Pulmonary hemorrhage or bleeding event ≥ CTCAE grade 2 within the past 4 weeks
• Any other hemorrhage or bleeding event ≥ CTCAE Grade 3 within the past 4 weeks
• Serious nonhealing wound, ulcer, or bone fracture
• Evidence or history of bleeding diathesis or coagulopathy
• Known or suspected allergy to sorafenib tosylate or any agent given in the course of this trial
• Any condition that impairs patient's ability to swallow whole pills
• Any malabsorption problem
• Significant traumatic injury within the past 4 weeks

PRIOR CONCURRENT THERAPY:

Inclusion criteria:

• Recovered from exploratory thoracotomy
• Concurrent anti-coagulation treatment with an agent such as warfarin or heparin allowed provided INR or PT/PTT requirements are met

Exclusion criteria:

• Prior systemic chemotherapy for lung cancer and/or thoracic/neck radiotherapy for any reason
• Prior surgical resection of present cancer
• Prior therapy with any molecular-targeted drugs (for lung cancer)
• Currently participating in other phase III therapeutic clinical trials and/or who have participated in other phase III therapeutic clinical trials in the previous 30 days
• Major surgery or open biopsy within the past 4 weeks
• Concurrent Hypericum perforatum (St. John's wort) or rifampin (rifampicin)

• Other concurrent anticancer drugs, including hormonal, immunotherapeutic, or chemotherapeutic agents

  • Steroids for acute symptom management, adrenal failure, septic shock, or as antiemetics allowed
  • Hormones administered for nondisease-related conditions (e.g., insulin for diabetes) allowed
• Amifostine concurrently with radiotherapy or within 3 months of completion of radiotherapy
• Concurrent colony-stimulating factors (i.e., filgrastim [G-CSF] or sargramostim [GM-CSF])