Pemetrexed Disodium and Bevacizumab in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer
Lung Cancer

About this trial
This is an interventional treatment trial for Lung Cancer focused on measuring recurrent non-small cell lung cancer, squamous cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically diagnosed stage IIIB or IV non-small cell lung cancer Stage IIIB patients must have pleural effusion No symptomatic serosal effusion (grade 2 dyspnea) that is not amenable to drainage Mixed histology allowed if all components consistent with non-small cell lung cancer Tumors with squamous cell histology feature are allowed Must have measurable disease with at least one lesion with a longest diameter accurately measured as ≥ 2.0 cm with conventional techniques or as ≥ 1.0 cm with spiral CT Large ( > 4 cm) centrally located lesions or large lesions in close proximity to major blood vessels should receive palliative radiation The irradiated lesion should not be a target lesion Previously treated with one chemotherapy regimen in the neoadjuvant, adjuvant, or advanced disease setting No symptomatic, untreated, or uncontrolled CNS metastases CNS metastases treated with prior whole brain radiotherapy allowed PATIENT CHARACTERISTICS: ECOG performance status 0-2 Life expectancy ≥ 12 weeks Absolute neutrophil count ≥ 1,500/mm^3 Platelet count ≥ 100,000/ mm^3 Hemoglobin ≥ 9 g/dL Bilirubin ≤ 1.5 times upper limit of normal (ULN) or direct bilirubin normal AST and ALT ≤ 3 times ULN (5 times ULN if liver has tumor involvement) Creatinine clearance ≥ 45 mL/min Urine protein:creatinine ratio < 1.0 Pregnant or nursing women are ineligible Negative pregnancy test Fertile patients must use effective contraception during and for 3 months after study participation No seizure disorder No clinically significant infection No other second primary malignancy within the past 5 years except carcinoma in situ of the cervix, non-melanomatous skin cancer, or low-grade (Gleason score ≤ 6) localized prostate cancer No hypertension or labile hypertension No history of poor compliance with antihypertensive medications No angina pectoris No congestive heart failure within the past 3 months unless ejection fraction > 40% No myocardial infarction within the past 6 months No cardiac arrhythmia No interstitial pneumonia or extensive and symptomatic interstitial fibrosis of the lung No active or recent history of hemoptysis Hemoptysis resolved > 2 weeks ago with measures such as palliative radiation therapy (i.e., 3,000 cGy over 10 fractions), arteriographic embolization, or endobronchial interventions (e.g., photodynamic therapy or brachytherapy) is acceptable No diabetes No prior serious, non-healing wounds, ulcers, or bone fractures No history of stroke within the past 6 months No history of abdominal fistula or gastrointestinal perforation No intra-abdominal abscess within the past 6 months Not at greater than average risk of bleeding No significant traumatic injury within the past 4 weeks PRIOR CONCURRENT THERAPY: No aspirin at doses ≥ 1.3 grams per day within 10 days prior to or 10 days after pemetrexed disodium treatment No chemotherapy within the past 3 weeks (6 weeks for mitomycin C or nitrosoureas) No immunotherapy or biologic therapy within the past 2 weeks No full field radiation therapy within the past 4 weeks or limited field radiation therapy within the past 2 weeks The site of previous radiotherapy should have evidence of progressive disease if it is the only site of disease No prior post pelvic radiation No prior use of pemetrexed disodium No prior radiation to > 25% of the marrow cavity No major surgery (i.e., laparotomy) or open biopsy within the past 4 weeks No minor surgery within the past 2 weeks except insertion of a vascular access device No concurrent major surgery No other chemotherapy, immunotherapy, hormonal therapy, radiotherapy, or any ancillary therapy considered investigational within the past 4 weeks No concurrent use of Hypericum perforatum (St. John's wort) No concurrent anticoagulant use Low-dose warfarin or heparin for deep venous thrombosis prophylaxis allowed
Sites / Locations
- Providence Cancer Center
- Mayo Clinic Scottsdale
- Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
- Eden Medical Center
- Saint Rose Hospital
- Highland General Hospital at St. George's University School of Medicine
- Alta Bates Summit Medical Center - Summit Campus
- CCOP - Bay Area Tumor Institute
- Valley Care Medical Center
- Doctors Medical Center - San Pablo Campus
- Mayo Clinic - Jacksonville
- Piedmont Hospital
- Northside Hospital Cancer Center
- Saint Joseph's Hospital of Atlanta
- CCOP - Atlanta Regional
- WellStar Cobb Hospital
- Charles B. Eberhart Cancer Center at DeKalb Medical Center
- Gwinnett Medical Center
- Kennestone Cancer Center at Wellstar Kennestone Hospital
- Southern Regional Medical Center
- Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
- Pearlman Comprehensive Cancer Center at South Georgia Medical Center
- Saint Anthony's Hospital at Saint Anthony's Health Center
- Rush-Copley Cancer Care Center
- St. Joseph Medical Center
- Graham Hospital
- Memorial Hospital
- Eureka Community Hospital
- Galesburg Clinic
- Galesburg Cottage Hospital
- Mason District Hospital
- Hopedale Medical Complex
- Joliet Oncology-Hematology Associates, Limited - West
- McDonough District Hospital
- Cardinal Bernardin Cancer Center at Loyola University Medical Center
- Good Samaritan Regional Health Center
- BroMenn Regional Medical Center
- Community Cancer Center
- Community Hospital of Ottawa
- Oncology Hematology Associates of Central Illinois, PC - Ottawa
- Cancer Treatment Center at Pekin Hospital
- Proctor Hospital
- CCOP - Illinois Oncology Research Association
- Oncology Hematology Associates of Central Illinois, PC - Peoria
- Methodist Medical Center of Illinois
- OSF St. Francis Medical Center
- Illinois Valley Community Hospital
- Perry Memorial Hospital
- St. Margaret's Hospital
- Carle Cancer Center at Carle Foundation Hospital
- CCOP - Carle Cancer Center
- St. Francis Hospital and Health Centers - Beech Grove Campus
- Saint Anthony Memorial Health Centers
- Reid Hospital & Health Care Services, Incorporated
- McFarland Clinic, PC
- Cedar Rapids Oncology Associates
- Genesis Regional Cancer Center at Genesis Medical Center
- Mercy Capitol Hospital
- CCOP - Iowa Oncology Research Association
- John Stoddard Cancer Center at Iowa Methodist Medical Center
- Medical Oncology and Hematology Associates at John Stoddard Cancer Center
- Medical Oncology and Hematology Associates at Mercy Cancer Center
- Mercy Cancer Center at Mercy Medical Center - Des Moines
- John Stoddard Cancer Center at Iowa Lutheran Hospital
- Mercy Cancer Center at Mercy Medical Center - North Iowa
- McCreery Cancer Center at Ottumwa Regional
- Siouxland Hematology-Oncology Associates, LLP
- Siouxland Regional Cancer Center
- Mercy Medical Center - Sioux City
- St. Luke's Regional Medical Center
- Cancer Center of Kansas, PA - Chanute
- Cancer Center of Kansas, PA - Dodge City
- Cancer Center of Kansas, PA - El Dorado
- Cancer Center of Kansas, PA - Kingman
- Southwest Medical Center
- Cancer Center of Kansas, PA - Newton
- Cancer Center of Kansas, PA - Parsons
- Cancer Center of Kansas, PA - Pratt
- Cancer Center of Kansas, PA - Salina
- Tammy Walker Cancer Center at Salina Regional Health Center
- Cancer Center of Kansas, PA - Wellington
- Associates in Womens Health, PA - North Review
- Cancer Center of Kansas, PA - Medical Arts Tower
- Cancer Center of Kansas, PA - Wichita
- CCOP - Wichita
- Via Christi Cancer Center at Via Christi Regional Medical Center
- Cancer Center of Kansas, PA - Winfield
- Cancer Research Center at Boston Medical Center
- Saint Joseph Mercy Cancer Center
- CCOP - Michigan Cancer Research Consortium
- Oakwood Cancer Center at Oakwood Hospital and Medical Center
- Green Bay Oncology, Limited - Escanaba
- Genesys Hurley Cancer Institute
- Hurley Medical Center
- Van Elslander Cancer Center at St. John Hospital and Medical Center
- Green Bay Oncology, Limited - Iron Mountain
- Foote Hospital
- Sparrow Regional Cancer Center
- Ted B. Wahby Cancer Center at Mount Clemens General Hospital
- Seton Cancer Institute - Saginaw
- St. John Macomb Hospital
- MeritCare Clinic - Bemidji
- Fairview Ridges Hospital
- Mercy and Unity Cancer Center at Mercy Hospital
- CCOP - Duluth
- Miller-Dwan Medical Center
- St. Mary's - Duluth Clinic Cancer Center
- Fairview Southdale Hospital
- Mercy and Unity Cancer Center at Unity Hospital
- Hutchinson Area Health Care
- Meeker County Memorial Hospital
- HealthEast Cancer Care at St. John's Hospital
- Minnesota Oncology Hematology, PA at Maplewood Cancer Center
- Virginia Piper Cancer Institute at Abbott-Northwestern Hospital
- Hennepin County Medical Center - Minneapolis
- Chippewa County - Montevideo Hospital
- Hubert H. Humphrey Cancer Center at North Memorial Medical Center
- Mayo Clinic Cancer Center
- Coborn Cancer Center
- CCOP - Metro-Minnesota
- Saint Francis Cancer Center
- St. Joseph's Hospital
- CentraCare Clinic - River Campus
- Park Nicollet Health Services
- Regions Hospital Cancer Care Center
- United Hospital
- Ridgeview Medical Center
- Minnesota Oncology Hematology, PA - Woodbury
- Woodwinds Health Campus
- Regional Cancer Center at Singing River Hospital
- Saint Francis Medical Center
- Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital
- CCOP - Kansas City
- Arch Medical Services, Incorporated at Center for Cancer Care Research
- David C. Pratt Cancer Center at St. John's Mercy
- CCOP - Cancer Research for the Ozarks
- St. John's Regional Health Center
- Hulston Cancer Center at Cox Medical Center South
- Missouri Baptist Cancer Center
- CCOP - St. Louis-Cape Girardeau
- CCOP - Montana Cancer Consortium
- Hematology-Oncology Centers of the Northern Rockies - Billings
- Northern Rockies Radiation Oncology Center
- St. Vincent Healthcare
- Billings Clinic Cancer Center
- Deaconess Billings Clinic - Downtown
- Bozeman Deaconess Hospital
- St. James Community Hospital
- Big Sky Oncology
- Sletten Regional Cancer Institute at Benefis Healthcare
- St. Peter's Hospital
- Glacier Oncology, PLLC
- Kalispell Medical Oncology
- Kalispell Regional Medical Center
- Community Medical Center
- Guardian Oncology and Center for Wellness
- Montana Cancer Specialists at Montana Cancer Center
- Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
- Good Samaritan Cancer Center at Good Samaritan Hospital
- Cancer Resource Center - Lincoln
- CCOP - Missouri Valley Cancer Consortium
- Adirondack Cancer Care - Glens Falls
- Randolph Hospital
- Wayne Memorial Hospital, Incorporated
- Moses Cone Regional Cancer Center at Wesley Long Community Hospital
- Pardee Memorial Hospital
- Annie Penn Cancer Center
- Rutherford Hospital
- Iredell Memorial Hospital
- Bismarck Cancer Center
- Cancer Care Center at Medcenter One Hospital
- Mid Dakota Clinic, PC
- St. Alexius Medical Center
- CCOP - MeritCare Hospital
- MeritCare Medical Group
- Altru Cancer Center at Altru Hospital
- Adena Regional Medical Center
- Riverside Methodist Hospital Cancer Care
- CCOP - Columbus
- Grant Riverside Cancer Services
- Mount Carmel Health - West Hospital
- Doctors Hospital at Ohio Health
- Grandview Hospital
- Good Samaritan Hospital
- David L. Rike Cancer Center at Miami Valley Hospital
- Samaritan North Cancer Care Center
- Veterans Affairs Medical Center - Dayton
- CCOP - Dayton
- Grady Memorial Hospital
- Blanchard Valley Medical Associates
- Charles F. Kettering Memorial Hospital
- Fairfield Medical Center
- Strecker Cancer Center at Marietta Memorial Hospital
- Middletown Regional Hospital
- Licking Memorial Cancer Care Program at Licking Memorial Hospital
- Mercy Medical Center
- Community Hospital of Springfield and Clark County
- UVMC Cancer Care Center at Upper Valley Medical Center
- Mount Carmel Cancer Services at Mount Carmel St. Ann's Hospital
- United States Air Force Medical Center - Wright-Patterson
- Ruth G. McMillan Cancer Center at Greene Memorial Hospital
- Genesis - Good Samaritan Hospital
- Natalie Warren Bryant Cancer Center at St. Francis Hospital
- Legacy Mount Hood Medical Center
- Providence Milwaukie Hospital
- Legacy Good Samaritan Hospital & Medical Center Comprehensive Cancer Center
- Providence Cancer Center at Providence Portland Medical Center
- CCOP - Columbia River Oncology Program
- Providence St. Vincent Medical Center
- Legacy Emanuel Hospital and Health Center & Children's Hospital
- Salem Hospital Regional Cancer Care Services
- Legacy Meridian Park Hospital
- Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
- Guthrie Cancer Center at Guthrie Clinic Sayre
- AnMed Health Cancer Center
- Hollings Cancer Center at Medical University of South Carolina
- CCOP - Upstate Carolina
- Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
- Rapid City Regional Hospital
- Avera Cancer Institute
- Medical X-Ray Center, PC
- Sioux Valley Hospital and University of South Dakota Medical Center
- Thompson Cancer Survival Center
- M.D. Anderson Cancer Center at University of Texas
- Danville Regional Medical Center
- St. Joseph Cancer Center
- Olympic Hematology and Oncology
- Fred Hutchinson Cancer Research Center
- Harborview Medical Center
- Minor and James Medical, PLLC
- Group Health Central Hospital
- Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
- Polyclinic First Hill
- University Cancer Center at University of Washington Medical Center
- Cancer Care Northwest - Spokane South
- Southwest Washington Medical Center Cancer Center
- Wenatchee Valley Medical Center
- Green Bay Oncology, Limited at St. Vincent Hospital
- Green Bay Oncology, Limited at St. Mary's Hospital
- St. Mary's Hospital Medical Center - Green Bay
- St. Vincent Hospital Regional Cancer Center
- Franciscan Skemp Healthcare
- Bay Area Cancer Care Center at Bay Area Medical Center
- Green Bay Oncology, Limited - Oconto Falls
- Green Bay Oncology, Limited - Sturgeon Bay
- Welch Cancer Center at Sheridan Memorial Hospital
Arms of the Study
Arm 1
Experimental
pemetrexed + bevacizumab
Patients receive pemetrexed disodium IV over 10 minutes and bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed periodically for 5 years.