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Clinical Trials (PDQ®)

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

Basic Trial Information
Trial Description
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIITreatmentClosed18 and overNCINCI-2009-00509
ECOG-E1505, CDR0000475774, E1505, U10CA180820, U10CA021115, SWOG-E1505, CALGB-E1505, CAN-NCIC-E1505, NCCTG-E1505, NCT00324805

Trial Description


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.

Further Study Information


I. To evaluate overall survival with chemotherapy with or without bevacizumab used in the adjuvant setting in patients with resected stage IB (>= 4 cm) - IIIA non-small cell lung cancer (NSCLC).


I. To evaluate disease-free survival and toxicity with chemotherapy with or without bevacizumab used in the adjuvant setting in patients with resected stage IB (>= 4 cm) - IIIA NSCLC.

II. To perform analyses of tissue and blood to establish factors that predict clinical outcome in patients receiving chemotherapy, with or without bevacizumab, for resected early stage NSCLC.

III. To determine whether smoking status is linked to outcome for patients with resected stage IB (>= 4 cm) - IIIA NSCLC treated with chemotherapy with or without bevacizumab in the adjuvant setting.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I (adjuvant chemotherapy without bevacizumab): Patients receive 1 of 4 chemotherapy regimens.

REGIMEN 1: Patients receive vinorelbine ditartrate intravenously (IV) over 10 minutes on days 1 and 8 and cisplatin IV over 60 minutes on day 1 immediately following vinorelbine ditartrate administration.

REGIMEN 2: Patients receive docetaxel IV over 1 hour on day 1 and cisplatin over 1 hour on day 1 immediately following docetaxel administration.

REGIMEN 3: Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and cisplatin IV over 60 minutes on day 1 immediately following gemcitabine administration.

REGIMEN 4 (non-squamous histology only): Patients receive pemetrexed disodium IV over 10 minutes and cisplatin IV over 1 hour on day 1 immediately following pemetrexed disodium administration.

In all regimens, treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.

ARM II (adjuvant chemotherapy with bevacizumab): Patients receive chemotherapy as in Arm I. Patients also receive bevacizumab IV over 30-90 minutes on day 1. Treatment with bevacizumab repeats every 21 days for up to 1 year.

After completion of study treatment, patients are followed up periodically for 10 years.

Eligibility Criteria

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

Trial Contact Information

Trial Lead Organizations/Sponsors

National Cancer Institute

Cancer and Leukemia Group B

NCIC-Clinical Trials Group

North Central Cancer Treatment Group

Southwest Oncology Group

Heather WakeleePrincipal Investigator

Trial Sites

 California Cancer Center - Woodward Park Office
 Dina Ibrahim Ph: 559-447-4050
  Long Beach
 Todd Cancer Institute at Long Beach Memorial Medical Center
 Robert A Nagourney Ph: 562-933-0900
  Los Angeles
 Kaiser Permanente Medical Center - Los Angeles
 Han A Koh Ph: 626-564-3455
 Robert and Beverly Lewis Family Cancer Care Center at Pomona Valley Hospital Medical Center
 Swapnil P Rajurkar Ph: 909-596-5333
  Saint Helena
 Saint Helena Hospital
 Gregory B Smith Ph: 707-967-3698
  San Francisco
 UCSF Helen Diller Family Comprehensive Cancer Center
 Thierry Jahan Ph: 877-827-3222
  Santa Clara
 Kaiser Permanente Medical Center - Santa Clara Homestead Campus
 Louis Fehrenbacher Ph: 626-564-3455
 Bridgeport Hospital
 Neal A Fischbach Ph: 203-384-4869
 Connecticut Oncology & Hematology - Torrington
 Michael C. Magnifico Ph: 860-482-5384
 Florida Hospital Cancer Institute at Florida Hospital Orlando
 Lee M. Zehngebot Ph: 407-303-5623
 CCOP - Atlanta Regional
 Thomas E. Seay Ph: 404-303-3355
 Northside Hospital Cancer Center
 Thomas E. Seay Ph: 404-303-3355
 Piedmont Hospital
 Thomas E. Seay Ph: 404-303-3355
 Saint Joseph's Hospital of Atlanta
 Thomas E. Seay Ph: 404-303-3355
 WellStar Cobb Hospital
 Thomas E. Seay Ph: 404-303-3355
 John B. Amos Cancer Center
 Thomas E. Seay Ph: 404-303-3355
 Charles B. Eberhart Cancer Center at DeKalb Medical Center
 Thomas E. Seay Ph: 404-303-3355
 Piedmont Fayette Hospital
 Thomas E. Seay Ph: 404-303-3355
 Gwinnett Medical Center
 Thomas E. Seay Ph: 404-303-3355
 Kennestone Cancer Center at Wellstar Kennestone Hospital
 Thomas E. Seay Ph: 404-303-3355
 Southern Regional Medical Center
 Thomas E. Seay Ph: 404-303-3355
 Harbin Clinic Cancer Center - Medical Oncology
 Thomas E. Seay Ph: 404-303-3355
 Saint John's Health System
 Robert C Ash Ph: 765-646-8358
  Beech Grove
 St. Francis Hospital and Health Centers - Beech Grove Campus
 Howard M. Gross Ph: 765-983-3000
  Fort Wayne
 Fort Wayne Medical Oncology and Hematology
 Sreenivasa Rao Nattam Ph: 260-484-8830
 Community Hospital
 Erwin L. Robin Ph: 708-915-6747
  Mason City
 Mercy Cancer Center at Mercy Medical Center - North Iowa
 Walter W. Bate Ph: 800-433-3883
 Central Maine Comprehensive Cancer Center at Central Maine Medical Center
 Nicholette Erickson Ph: 207-795-8250
 Genesys Hurley Cancer Institute
 Philip J. Stella Ph: 734-712-3456
  Kessler AFB
 Keesler Air Force Base Medical Center
 Louis M Varner Ph: 800-700-8603
 Saint Luke's Hospital
 Donald F. Busiek Ph: 314-205-6936
  Las Vegas
 Nevada Cancer Institute
 Robert P. Whitehead Ph: 702-822-5136
New Hampshire
 Center for Cancer Care at Exeter Hospital
 Michael S Buff Ph: 800-339-6484
New Jersey
 AtlantiCare Regional Medical Center - Atlantic City Campus
 Julianne Wilkins Childs Ph: 609-748-7200
 Valley Hospital - Ridgewood
 Eli D Kirshner Ph: 201-634-5792
New Mexico
 Presbyterian Cancer Treatment Center at Presbyterian Kaseman Hospital
 Montaser Shaheen Ph: 505-272-6972
New York
 Bassett Healthcare Regional Cancer Program at Mary Imogene Bassett Hospital
 Eric Bravin Ph: 607-547-6965
 Falck Cancer Center at Arnot Ogden Medical Center
 Jonathan W Friedberg Ph: 585-275-5830
North Carolina
 Veterans Affairs Medical Center - Durham
 Sally J York Ph: 800-811-8480
North Dakota
 Bismarck Cancer Center
 Edward J. Wos Ph: 701-323-5760
 Knight Cancer Institute at Oregon Health and Science University
 Alan B. Sandler Ph: 503-494-1080
South Carolina
 AnMed Cancer Center
 Charles E Bowers Ph: 800-486-5941
West Virginia
 Schiffler Cancer Center at Wheeling Hospital
 Manish Monga Ph: 304-293-2745
 Vince Lombardi Cancer Clinic - Oshkosh
 Zahid N Dar Ph: 800-252-2990
 All Saints Cancer Center at Wheaton Franciscan Healthcare
 Young M Choi Ph: 414-874-4541

Link to the current record.
NLM Identifer NCT00324805 processed this data on April 22, 2015

Note: Information about this trial is from the database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the record to standardize the names of study sponsors, sites, and contacts. only lists sites that are recruiting patients for active trials, whereas lists all sites for all trials. Questions and comments regarding the presented information should be directed to

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