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NCT00324805

PHASE3

Chemotherapy With or Without Bevacizumab in Treating Patients With Stage IB, Stage II, or Stage IIIA Non-small Cell Lung Cancer That Was Removed By Surgery

Sponsor: National Cancer Institute (NCI)

View on ClinicalTrials.gov

Summary

This randomized phase III trial studies chemotherapy and bevacizumab to see how well they work compared to chemotherapy alone in treating patients with stage IB, stage II, or stage IIIA non-small cell lung cancer that was removed by surgery. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Monoclonal antibodies, such as bevacizumab, may interfere with the ability of tumor cells to grow and spread. Bevacizumab also may stop the growth of non-small cell lung cancer by blocking the growth of new blood vessels necessary for tumor growth. It is not yet known whether chemotherapy is more effective with or without bevacizumab in treating non-small cell lung cancer.

Official title: A Phase III Randomized Trial of Adjuvant Chemotherapy With or Without Bevacizumab for Patients With Completely Resected Stage IB (≥ 4 cm) - IIIA Non-small Cell Lung Cancer (NSCLC)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1501

Start Date

2007-07-19

Completion Date

2025-01-31

Last Updated

2026-06-23

Healthy Volunteers

Conditions

Stage IB Lung Non-Small Cell Carcinoma AJCC v7 Stage IIA Lung Non-Small Cell Carcinoma AJCC v7 Stage IIB Lung Non-Small Cell Carcinoma AJCC v7 Stage IIIA Lung Non-Small Cell Cancer AJCC v7

Interventions

BIOLOGICAL

Bevacizumab

Given IV

DRUG

Cisplatin

Given IV

DRUG

Docetaxel

Given IV

DRUG

Gemcitabine Hydrochloride

Given IV

OTHER

Laboratory Biomarker Analysis

Correlative studies

DRUG

Pemetrexed Disodium

Given IV

OTHER

Questionnaire Administration

Ancillary studies

DRUG

Vinorelbine Tartrate

Given IV

Inclusion Criteria: * In order to be eligible for this trial, patients must have undergone complete resection of their non-small cell lung cancer (NSCLC) \[stage IB (\>= 4 cm)\] - \[IIIA (T2-3N0, T1-3N1, T1-3N2\] prior to enrollment; accepted types of resection will consist of lobectomy, sleeve lobectomy, bi-lobectomy or pneumonectomy; resections by segmentectomy or wedge resection will not be accepted; mediastinal lymph node sampling at specified levels is required pre-operatively (mediastinoscopy) or intraoperatively (level 7 and 4 for right sided tumors or level 7 and 5 and/or 6 for left sided tumors) * Patients must be no less than 6 weeks (42 days) and no more than 12 weeks (84 days) post-thoracotomy at the time of randomization and must be adequately recovered from surgery * Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 * Patients must not have received the following: * Prior systemic chemotherapy at any time; methotrexate (MTX) given in low doses for non-malignant conditions with last dose at least 2 weeks prior to date of registration will be allowed; other low dose chemotherapeutics for non-malignant conditions will be considered, but review by the study chair is required * Hormonal cancer therapy or radiation therapy as prior cancer treatment within 5 years of randomization; (prior surgery, biologic therapy, hormonal therapy, or radiation therapy for a malignancy over 5 years prior to enrollment that is now considered cured is acceptable) * Patients must not have any history of cancer within 5 years from randomization, with the exception of in-situ carcinoma of the cervix or completely resected non-melanoma skin cancer * Absolute neutrophil count (ANC) \>= 1500 mm\^3 * Platelets \>= 100,000/mm\^3 * Prothrombin time/international normalized ratio (INR) =\< 1.5 * Or, if patient is on therapeutic anticoagulation, prothrombin time/INR =\< 3.0 * Partial thromboplastin time (PTT) =\< institutional upper limit of normal (ULN) OR, if patient is on therapeutic anticoagulation, PTT must be =\< 1.5 x ULN * Total bilirubin =\< 1.5 mg/dL * Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase \[AST\]) \< 5 x upper limit of normal (ULN) * Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase \[ALT\]) \< 5 x upper limit of normal (ULN) * Serum creatinine =\< 1.5 x institutional upper limit of normal (ULN) * Urine protein should be screened by urine analysis for urine protein creatinine (UPC) ratio; for UPC ratio \> 0.5, 24-hour urine protein must be obtained and the level must be \< 1000 mg (1 g) for patient enrollment * Patients with a known history of myocardial infarction or other evidence of arterial thrombotic disease (angina) will be allowed on study only if they have had no evidence of active disease for at least 12 months prior to randomization * Patients with any history of cerebral vascular accident (CVA) or transient ischemic attack (TIA) will not be allowed on trial * Women must not be pregnant or breast-feeding * All females of childbearing potential must have a blood or urine test within 2 weeks prior to randomization to rule out pregnancy * Both fertile men and women must agree to use adequate contraceptive measures during study treatment and for at least 6 months after completion of bevacizumab * Patients must not have any clinically significant ongoing, active or serious infection, symptomatic or uncontrolled congestive heart failure, symptomatic or uncontrolled cardiac arrhythmia or any other medical condition or psychiatric illness/social situations that would limit compliance with study requirements * Patients must have no history of bleeding diathesis or coagulopathy * All patients must have a documented blood pressure (BP) with systolic =\< 150 and diastolic =\< 90 within 28 days of registration; patients with known hypertension must be on a stable regimen of anti-hypertensive therapy * Patients receiving daily treatment with aspirin or non-steroidal anti-inflammatory agents (NSAIDS) are eligible; treatment with dipyridamole (Persantine), ticlopine (Ticlid), clopidogrel (Plavix) and/or cilostazol (Pletal) is not allowed; patients must have stopped taking any of these agents at least 7 days prior to randomization * Patients must not have serious non-healing wound, ulcer, bone fracture, or have undergone a major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to randomization OR core biopsy within 7 days prior to randomization * Patients must not have a history of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 28 days prior to randomization * Patients must not have any anticipated major surgical procedure(s) during the course of the study * Patients must not have known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies * Patients may be on a stable regimen of therapeutic anticoagulation or may be receiving prophylactic anticoagulation of venous access devices, provided that coagulation studies meet entry criteria above; caution must be exercised for patients requiring anticoagulation, including treatment with low dose heparin or low molecular weight heparin for deep vein thrombosis (DVT) prophylaxis while on study * Patients with ongoing post-operative hemoptysis (defined as bright red blood of 1/2 teaspoon or more) are not eligible; patients with pre-operative hemoptysis that has resolved post-operatively are eligible * Patients who will receive pemetrexed (pemetrexed disodium)/cisplatin therapy must also meet the following criteria: * Patients assigned to pemetrexed/cisplatin therapy must NOT have squamous cell histology * Calculated creatinine clearance must be obtained within 2 weeks of randomization and calculated creatinine clearance (CrCl) must be \>= 45 mL/min using the standard Cockcroft and Gault formula, or the measured glomerular filtration rate (GFR) using the appropriate radiolabeled method (\[51\]chromium-labeled ethylenediaminetetraacetic acid \[51-CrEDTA\] or technetium 99m diethylenetriamine-pentaacetic acid \[Tc99m-DTPA\]) must be used to calculate CrCl

Locations (1169)

Northeast Alabama Regional Medical Center

Anniston, Alabama, United States

Clearview Cancer Institute

Huntsville, Alabama, United States

Providence Hospital

Mobile, Alabama, United States

University of South Alabama Mitchell Cancer Institute

Mobile, Alabama, United States

Alaska Regional Hospital

Anchorage, Alaska, United States

Providence Alaska Medical Center

Anchorage, Alaska, United States

Mayo Clinic in Arizona

Scottsdale, Arizona, United States

University of Arizona Cancer Center-Orange Grove Campus

Tucson, Arizona, United States

Banner University Medical Center - Tucson

Tucson, Arizona, United States

University of Arizona Cancer Center-North Campus

Tucson, Arizona, United States

Mercy Hospital Fort Smith

Fort Smith, Arkansas, United States

NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro

Jonesboro, Arkansas, United States

NEA Baptist Memorial Hospital

Jonesboro, Arkansas, United States

Saint Bernards Regional Medical Center

Jonesboro, Arkansas, United States

John L McClellan Memorial Veterans Hospital

Little Rock, Arkansas, United States

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Kaiser Permanente-Anaheim

Anaheim, California, United States

Kaiser Permanente-Deer Valley Medical Center

Antioch, California, United States

PCR Oncology

Arroyo Grande, California, United States

Kaiser Permanente-Baldwin Park

Baldwin Park, California, United States

Kaiser Permanente-Bellflower

Bellflower, California, United States

Alta Bates Summit Medical Center-Herrick Campus

Berkeley, California, United States

Providence Saint Joseph Medical Center/Disney Family Cancer Center

Burbank, California, United States

Mills-Peninsula Medical Center

Burlingame, California, United States

East Bay Radiation Oncology Center

Castro Valley, California, United States

Eden Hospital Medical Center

Castro Valley, California, United States

Valley Medical Oncology Consultants-Castro Valley

Castro Valley, California, United States

Adventist Health Cancer Care Center Chico

Chico, California, United States

Community Cancer Institute

Clovis, California, United States

City of Hope Comprehensive Cancer Center

Duarte, California, United States

Bay Area Breast Surgeons Inc

Emeryville, California, United States

Epic Care Partners in Cancer Care

Emeryville, California, United States

Kaiser Permanente-Fontana

Fontana, California, United States

Kaiser Permanente-Fremont

Fremont, California, United States

Valley Medical Oncology Consultants-Fremont

Fremont, California, United States

California Cancer Associates for Research and Excellence (cCare)

Fresno, California, United States

Kaiser Permanente-Fresno

Fresno, California, United States

Saint Jude Medical Center

Fullerton, California, United States

Glendale Memorial Hospital and Health Center

Glendale, California, United States

Marin Cancer Care Inc

Greenbrae, California, United States

Marin General Hospital

Greenbrae, California, United States

Kaiser Permanente South Bay

Harbor City, California, United States

Saint Rose Hospital

Hayward, California, United States

Kaiser Permanente-Irvine

Irvine, California, United States

Loma Linda University Medical Center

Loma Linda, California, United States

Long Beach Memorial Medical Center-Todd Cancer Institute

Long Beach, California, United States

Kaiser Permanente Los Angeles Medical Center

Los Angeles, California, United States

Los Angeles General Medical Center

Los Angeles, California, United States

USC / Norris Comprehensive Cancer Center

Los Angeles, California, United States

Kaiser Permanente West Los Angeles

Los Angeles, California, United States

Contra Costa Regional Medical Center

Martinez, California, United States

Fremont - Rideout Cancer Center

Marysville, California, United States

Mercy Cancer Center

Merced, California, United States

Memorial Medical Center

Modesto, California, United States

Kaiser Permanente-Modesto

Modesto, California, United States

Community Hospital of Monterey Peninsula

Monterey, California, United States

El Camino Hospital

Mountain View, California, United States

Palo Alto Medical Foundation-Camino Division

Mountain View, California, United States

Sutter Cancer Research Consortium

Novato, California, United States

Highland General Hospital