Bevacizumab, Paclitaxel, and Carboplatin Before Surgery in Treating Patients With Stage IB, Stage II, or Stage IIIA Non-Small Cell Lung Cancer
Lung Cancer

About this trial
This is an interventional treatment trial for Lung Cancer focused on measuring stage I non-small cell lung cancer, stage II non-small cell lung cancer, stage IIIA non-small cell lung cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed non-small cell lung cancer Stage IB (T2, N0), II (T1 or T2, N1 or T3, N0), or IIIA (T3, N1) Potentially resectable disease No large central primary tumors in proximity to significant blood vessels No bronchoscopically evident endobronchial tumors At least 1 unidimensionally measurable lesion At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan No known brain metastases PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 OR Karnofsky 70-100% Life expectancy: More than 12 months Hematopoietic: WBC at least 3,000/mm^3 Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 No history of an inherited bleeding disorder No inherited predisposition to a hypercoagulable state No clinically evident hypercoagulable state or bleeding diathesis Hepatic: Bilirubin less than 1.5 times upper limit of normal (ULN) AST/ALT no greater than 2.5 times ULN INR less than 1.5 PTT less than 36 seconds Renal: Creatinine less than 1.5 times ULN OR Creatinine clearance at least 60 mL/min No nephrotic syndrome Urine protein no greater than 0.5 g/24 hours Cardiovascular: No poorly controlled hypertension (greater than 150 mm Hg systolic and/or greater than 100 mm Hg diastolic) despite treatment No uncompensated coronary artery disease No myocardial infarction within the past 6 months No clinically significant or severe peripheral vascular disease No inherited predisposition to thrombosis No deep venous or arterial thrombosis No symptomatic congestive heart failure No unstable angina pectoris within the past 6 months No cardiac arrhythmia No transient ischemic attack within the past 6 months No cerebrovascular accident within the past 6 months No other arterial thromboembolic event within the past 6 months Pulmonary: No hemoptysis No pulmonary embolism Other: No history of allergic reactions to compounds of similar chemical or biologic composition to study drugs No known hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanized antibodies Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No psychiatric illness or social situation that would preclude study compliance No significant traumatic injury within the past 28 days No uncontrolled concurrent illness No ongoing or active infection No serious, non-healing wound, ulcer, or bone fracture No other active malignancy No requirement for full-dose anticoagulation or thrombolytic therapy PRIOR CONCURRENT THERAPY: Biologic therapy: No prior biologic therapy for this cancer No concurrent prophylactic growth factors (e.g., epoetin alfa, filgrastim [G-CSF], or sargramostim [GM-CSF]) Chemotherapy: No prior chemotherapy for this cancer Prior chemotherapy for another malignancy allowed provided the prior malignancy was curatively treated and is currently controlled Endocrine therapy: No prior endocrine therapy for this cancer Radiotherapy: No prior radiotherapy for this cancer Prior radiotherapy for another malignancy allowed provided the prior malignancy was curatively treated and is currently controlled No concurrent radiotherapy Surgery: Prior diagnostic bronchoscopy, mediastinoscopy, or CT-guided biopsy allowed At least 28 days since prior major surgical procedure or open biopsy Other: No other concurrent investigational agents No other concurrent anticancer investigational or commercial agents or therapies No concurrent combination antiretroviral therapy for HIV-positive patients Concurrent low-dose warfarin for maintenence of preexisting, permanent, indwelling IV catheters allowed provided INR less than 1.5
Sites / Locations
- University of Chicago Cancer Research Center
- Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
Arms of the Study
Arm 1
Experimental
Arm A
Bevacizumab (15mg/kg, q3wk x 2), Paclitaxel (200 mg/m2, q3wk x 2), carboplatin (AUC of 6, q3wk x 2), followed by surgery 4 to 6 weeks after last dose of Bevacizumab