Combination Chemotherapy, Radiation Therapy, and Bevacizumab in Treating Patients With Newly Diagnosed Stage III Non-small Cell Lung Cancer That Cannot Be Removed by Surgery
Lung Adenocarcinoma, Lung Adenosquamous Carcinoma, Lung Large Cell Carcinoma
About this trial
This is an interventional treatment trial for Lung Adenocarcinoma
Eligibility Criteria
Inclusion Criteria: Histologically or cytologically confirmed single, primary, bronchogenic, non-small cell lung cancer (NSCLC) Newly diagnosed disease Unresectable disease No more than 1 parenchymal lesions on same or opposite sides of the lungs Meets 1 of the following stage criteria: Stage IIIA (N2) disease meeting the following criteria: N2 mediastinal lymph nodes must be multiple and/or bulky on CT scan or x-ray so that the patient is not a candidate for induction chemotherapy or chemoradiotherapy followed by surgical resection N2 status must be documented by ≥ 1 of the following methods: Histologically or cytologically confirmed N2 disease by exploratory thoracotomy, thoracoscopy, mediastinoscopy, mediastinotomy, Chamberlain procedure, Wang needle biopsy (WNB), fine needle aspiration (FNA) under bronchoscopic or CT guidance, or any other method Node positive by fludeoxyglucose-positron emission tomography (FDG-PET) scan Nodes > 3 cm on CT scan Paralyzed left true vocal cord with separate left lung primary distinct from anterior-posterior window nodes on CT scan Stage IIIB disease meeting ≥ 1 of the following criteria: Histologically or radiographically confirmed positive N3 nodes*, documented by ≥ 1 of the following methods: FNA, core needle biopsy (CNB), or excisional biopsy of supraclavicular N3 nodes Biopsy of contralateral mediastinal N3 nodes by mediastinoscopy, mediastinotomy, or thoracotomy FNA, CNB, or WNB under CT or bronchoscopic fluoroscopic guidance of enlarged contralateral N3 mediastinal nodes Contralateral mediastinal nodes > 3 cm on CT scan Node positivity by FDG-PET scan Right-sided primary with paralyzed left true vocal cord T4 lesions of any size that invade the mediastinum, heart, great vessels, trachea, esophagus, vertebral body, or carina, documented by ≥ 1 of the following methods: Written documentation of type of T4 extent if patient had a prior exploratory thoracotomy or thoracoscopy T4 involvement of the trachea or carina by direct bronchoscopic visualization T4 involvement of the heart, esophagus, aorta, or vertebral body by CT scan, MRI, or transesophageal ultrasound T4 involvement of the mediastinum by CT scan or MRI if, in the absence of the above organ involvement, there is soft tissue extension directly into the mediastinal space** Meets 1 of the following risk criteria: Low risk disease, meeting the following criteria: Non-squamous cell NSCLC, including adenocarcinoma, bronchoalveolar cell carcinoma, or large cell carcinoma If mixed histology, the squamous cell carcinoma component must be < 50% Histology or cytology from involved mediastinal or supraclavicular lymph nodes allowed if a separate distal primary lesion is clearly evident on radiographs (i.e., second biopsy not required) No primary tumor with cavitation and/or tumor within 1 cm of a major vessel No hemoptysis (i.e., bright red blood ≥ ½ teaspoon) in the past 28 days High-risk* disease, meeting ≥ 1 of the following criteria: Squamous cell NSCLC If mixed histology, the squamous cell component must be ≥ 50% Tumor with any histology that has cavitation or is located within 1 cm of a major vessel No aortic involvement Any histology and hemoptysis (i.e., bright red blood ≥ ½ teaspoon) within past 28 days Measurable or nonmeasurable disease by CT scan or MRI Pleural effusions, ascites, and laboratory parameters are not acceptable as the only evidence of disease No pleural effusion except for small pleural effusion visible on CT scan or MRI alone No pericardial effusions No metastatic disease involving the contralateral chest, liver, or adrenals confirmed by CT scan of the upper abdomen or by chest CT scan with complete liver and adrenals in the report Patients must be offered participation in SWOG-S9925 (Lung Cancer Specimen Repository Protocol) No brain metastases by CT scan or MRI No evidence of cavitation Creatinine normal Creatinine clearance ≥ 50 mL/min FEV_1 ≥ 2.0 liters OR predicted FEV_1 of the contralateral lung > 800 mL Absolute neutrophil count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 Urine protein: creatinine ratio ≤ 0.5 by urinalysis OR urine protein < 1,000 mg by 24-hour urine collection INR < 1.5 Zubrod performance status 0-1 No sensory neuropathy > grade 1 No cerebrovascular accident within the past 6 months No myocardial infarction or unstable angina within the past 6 months No uncontrolled hypertension No New York Heart Association class II-IV congestive heart failure No serious cardiac arrhythmia requiring medication No clinically significant peripheral vascular disease No evidence of bleeding diathesis or coagulopathy No pathologic condition other than lung cancer that carries a high risk of bleeding No known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies No serious, nonhealing wound, ulcer, or bone fracture No other prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer for which the patient is currently in complete remission, or other cancer for which the patient has been disease-free for 5 years Not pregnant or nursing No nursing during and for ≥ 6 months after the last dose of bevacizumab Negative pregnancy test Fertile patients must use effective contraception during and for ≥ 6 months after the last dose of bevacizumab Must have pre-treatment simulation demonstrating a V20 ≤ 35% with planned radiation dose of 6,480 cGy No prior surgical resection Prior exploratory thoracotomy, mediastinoscopy, excisional biopsy, or similar surgery allowed for diagnosing, staging, or determining potential resectability of lung tumor No prior chemotherapy or radiotherapy for lung cancer No prior radiotherapy to the neck or thorax At least 4 weeks since prior thoracic or other major surgery (excluding mediastinoscopy) and recovered More than 7 days since prior FNA, CNB, or mediastinoscopy No other concurrent anticancer therapy, including chemotherapy, radiotherapy, or biologic agents No other concurrent investigational drugs No concurrent major surgical procedures No concurrent full-dose anticoagulants (e.g., low-molecular weight and unfractionated heparin or warfarin) Low-dose warfarin (i.e., 1 mg) is allowed to prevent clotting of an infusaport or central line No concurrent brachytherapy, radiopharmaceuticals, high linear energy transfer radiation (i.e., fast neutrons), particle therapy (i.e., protons, carbon, or helium), and/or altered fractionation schemes No concurrent intensity-modulated radiotherapy No concurrent prophylactic contralateral hilar or supraclavicular lymph node radiotherapy
Sites / Locations
- Providence Hospital
- Saint Bernards Regional Medical Center
- University of Arkansas for Medical Sciences
- Highlands Oncology Group - Rogers
- USC / Norris Comprehensive Cancer Center
- Fremont - Rideout Cancer Center
- UC Irvine Health/Chao Family Comprehensive Cancer Center
- University of California Davis Comprehensive Cancer Center
- Providence Santa Rosa Memorial Hospital
- Gene Upshaw Memorial Tahoe Forest Cancer Center
- Northbay Cancer Center
- Rocky Mountain Regional VA Medical Center
- UCHealth University of Colorado Hospital
- Denver Health Medical Center
- University of Colorado
- Shaw Cancer Center
- Valley View Hospital Cancer Center
- Montrose Memorial Hospital
- Cancer Centers of Central Florida PA
- Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
- Loyola University Medical Center
- Edward Hospital/Cancer Center
- HaysMed University of Kansas Health System
- Hutchinson Regional Medical Center
- University of Kansas Cancer Center
- Olathe Cancer Center
- Salina Regional Health Center
- University of Kansas Health System Saint Francis Campus
- LSU Health Sciences Center at Shreveport
- Highland Clinic
- Steward Saint Elizabeth's Medical Center
- Wayne State University/Karmanos Cancer Institute
- McLaren Cancer Institute-Macomb
- University of Mississippi Medical Center
- Kansas City Veterans Affairs Medical Center
- Montana Cancer Consortium NCORP
- Benefis Healthcare- Sletten Cancer Institute
- Arnot Ogden Medical Center/Falck Cancer Center
- Highland Hospital
- University of Rochester
- Novant Health Presbyterian Medical Center
- Southeast Clinical Oncology Research Consortium NCORP
- Oregon Health and Science University
- Portland VA Medical Center
- Roper Hospital
- Wellmont Holston Valley Hospital and Medical Center
- University of Tennessee Health Science Center
- The Don and Sybil Harrington Cancer Center
- M D Anderson Cancer Center
- Audie L Murphy VA Hospital
- Cancer Therapy and Research Center at The UT Health Science Center at San Antonio
- University Hospital
- University of Texas Health Science Center at San Antonio
- Danville Regional Medical Center
- Southwest VA Regional Cancer Center
- MultiCare Auburn Medical Center
- Providence Regional Cancer System-Centralia
- Saint Francis Hospital
- Saint Clare Hospital
- Providence - Saint Peter Hospital
- MultiCare Good Samaritan Hospital
- MultiCare Allenmore Hospital
- Saint Joseph Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
Group 1 (cisplatin, etoposide, radiotherapy)
Group 2 (cisplatin, etoposide, radiotherapy, bevacizumab)
Group 3 (cisplatin, etoposide, radiotherapy, bevacizumab)
Patients receive cisplatin IV over 1 hour on days 1, 8, 29, and 36 and etoposide IV over 1 hour on days 1-5 and 29-33. Patients undergo concurrent thoracic radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, 36-40, and 43-47.
Patients receive cisplatin, etoposide, and thoracic radiotherapy as in group 1. Patients also receive bevacizumab IV over 30-90 minutes on days 15, 36, and 57.
Patients receive cisplatin, etoposide, and thoracic radiotherapy as in group 1. Patients also receive bevacizumab IV over 30-90 minutes on days 1, 22, and 43.