MnSOD-Plasmid Liposomes in Preventing Esophageal Toxicity in Patients With Locally Advanced Stage III Non-Small Cell Lung Cancer Undergoing Chemoradiotherapy

Inclusion Criteria

• Histologically or cytologically documented NSCLC, including squamous cell carcinoma, adenocarcinoma (including bronchoalveolar cell), and large cell anaplastic carcinoma (including giant and clear cell carcinomas) and poorly differentiated non-small cell lung cancer; totally resected tumors are excluded
• Patients must be without evidence of M0
• Patients with T1 or T2 disease with N2 or T3N1-2 disease (stage IIIA) are eligible if they are medically inoperable; patients with T4 with any N or any T with N3 disease are eligible; radiographic evidence of mediastinal lymph nodes > 2.0 cm in the largest diameter is sufficient to stage N2 or N3 disease; if the largest mediastinal node is < 2.0 cm in diameter and this is the basis for stage III disease, then at least one of the nodes must be proven positive cytologically or histologically
• Patients with tumors adjacent to a vertebral body are eligible 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
• Patients with a pleural effusion that is a transudate, cytologically negative and non-bloody are eligible if the radiation oncologists feel the tumor can still be encompassed within a reasonable field of radiotherapy; patients with exudative, bloody, or cytologically malignant effusions are ineligible; if a pleural effusion can be seen on the chest computed tomography (CT) but not on chest x-ray (CXR) and is too small to tap, the patient will be eligible
• Radiation oncology and medical oncology consults must deem patient suitable for protocol treatment
• Performance status >= 70 (Karnofsky performance scale)
• Weight loss =< 10% in 3 months prior to diagnosis
• No prior systemic chemotherapy, radiation therapy to the thorax, or total surgical resection
• At least 3 weeks since formal exploratory thoracotomy and patient has recovered from surgery, or 1 week from diagnostic thoracoscopy
• Granulocytes >= 2,000/ml
• Platelets >= 100,000/ml
• Hemoglobin > 8 mg/dl; Physician can maintain a patient's hemoglobin with the use of erythropoietin or transfusions (prophylactic use of G-CSF [filgrastim] is not permitted)
• Bilirubin < 1.5 x normal
• Creatinine clearance (24 hour or calculated) > 50 ml/min
• Forced expiratory volume in 1 second (FEV1) > 800 cc
• Patients must have a magnetic resonance imaging (MRI) or CT brain within 4 weeks prior to study entry to rule out asymptomatic brain metastases
• Informed Consent: Each patient must be aware of the neoplastic nature of his/her disease process and must willingly sign a study-specific consent prior to randomization after being informed of the procedures to be followed, the experimental nature of the therapy, alternatives, potential benefits, side effects, risks, and discomforts (human protection committee approval of this protocol and consent form is required)
• No active concurrent malignancy is allowed, except inactive non-melanoma skin cancer or in situ carcinoma of the cervix; prior cancer is eligible only if the patient has been disease-free for >= 5 years
• No serious medical or psychiatric illnesses that would prevent informed consent; patients with post-obstructive pneumonia are eligible; patients with an active serious infection or other serious underlying medical condition that would otherwise impair their ability to receive protocol treatment are ineligible
• Prior significant allergic reactions to drugs containing Cremophor, such as cyclosporine, or vitamin K are not eligible; a significant reaction may be defined as, but is not limited to, the description of grade = 3 allergic reactions using the Common Toxicity Criteria (CTC)
• No history of serious cardiac disease that is not adequately controlled; patients with documented myocardial infarction within 6 months prior to study entry, congestive heart failure, unstable angina, clinically significant pericardial effusion or arrhythmia are ineligible; an electrocardiogram (ECG) must be done within 4 weeks prior to study entry on all patients
• Nonpregnant, nonlactating female patients; patients of childbearing potential must implement an effective method of contraception during the study; all women of childbearing potential must have a pre-study negative serum or urine pregnancy test within 7 days prior to study entry