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

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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

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.

Further Study Information

PRIMARY OBJECTIVES:

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).

SECONDARY OBJECTIVES:

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 Wakelee, Principal Investigator

Trial Sites

U.S.A.

California
Fresno

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

Pomona

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

Connecticut
Bridgeport

Bridgeport Hospital

Neal A Fischbach
Ph: 203-384-4869

Torrington

Connecticut Oncology & Hematology - Torrington

Michael C. Magnifico
Ph: 860-482-5384

Florida
Orlando

Florida Hospital Cancer Institute at Florida Hospital Orlando

Lee M. Zehngebot
Ph: 407-303-5623

Georgia
Atlanta

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

Austell

WellStar Cobb Hospital

Thomas E. Seay
Ph: 404-303-3355

Columbus

John B. Amos Cancer Center

Thomas E. Seay
Ph: 404-303-3355

Decatur

Charles B. Eberhart Cancer Center at DeKalb Medical Center

Thomas E. Seay
Ph: 404-303-3355

Fayetteville

Piedmont Fayette Hospital

Thomas E. Seay
Ph: 404-303-3355

Lawrenceville

Gwinnett Medical Center

Thomas E. Seay
Ph: 404-303-3355

Marietta

Kennestone Cancer Center at Wellstar Kennestone Hospital

Thomas E. Seay
Ph: 404-303-3355

Riverdale

Southern Regional Medical Center

Thomas E. Seay
Ph: 404-303-3355

Rome

Harbin Clinic Cancer Center - Medical Oncology

Thomas E. Seay
Ph: 404-303-3355

Indiana
Anderson

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
Email: ledgar@fwmoh.com

Munster

Community Hospital

Erwin L. Robin
Ph: 708-915-6747

Iowa
Mason City

Mercy Cancer Center at Mercy Medical Center - North Iowa

Walter W. Bate
Ph: 800-433-3883

Maine
Lewiston

Central Maine Comprehensive Cancer Center at Central Maine Medical Center

Nicholette Erickson
Ph: 207-795-8250
Email: benderli@cmhc.org

Michigan
Flint

Genesys Hurley Cancer Institute

Philip J. Stella
Ph: 734-712-3456

Mississippi
Kessler AFB

Keesler Air Force Base Medical Center

Louis M Varner
Ph: 800-700-8603

Missouri
Chesterfield

Saint Luke's Hospital

Donald F. Busiek
Ph: 314-205-6936

Nevada
Las Vegas

Nevada Cancer Institute

Robert P. Whitehead
Ph: 702-822-5136

New Hampshire
Exeter

Center for Cancer Care at Exeter Hospital

Michael S Buff
Ph: 800-339-6484

New Jersey
Pomona

AtlantiCare Regional Medical Center - Atlantic City Campus

Julianne Wilkins Childs
Ph: 609-748-7200

Ridgewood

Valley Hospital - Ridgewood

Eli D Kirshner
Ph: 201-634-5792
Email: cparish@valleyhealth.com

New Mexico
Albuquerque

Presbyterian Cancer Treatment Center at Presbyterian Kaseman Hospital

Montaser Shaheen
Ph: 505-272-6972

New York
Cooperstown

Bassett Healthcare Regional Cancer Program at Mary Imogene Bassett Hospital

Eric Bravin
Ph: 607-547-6965
Email: jennifer.victory@bassett.org

Elmira

Falck Cancer Center at Arnot Ogden Medical Center

Jonathan W Friedberg
Ph: 585-275-5830

North Carolina
Durham

Veterans Affairs Medical Center - Durham

Sally J York
Ph: 800-811-8480

North Dakota
Bismarck

Bismarck Cancer Center

Edward J. Wos
Ph: 701-323-5760
Email: tfischer@mohs.org

Oregon
Portland

Knight Cancer Institute at Oregon Health and Science University

Alan B. Sandler
Ph: 503-494-1080
Email: trials@ohsu.edu

South Carolina
Anderson

AnMed Cancer Center

Charles E Bowers
Ph: 800-486-5941

West Virginia
Wheeling

Schiffler Cancer Center at Wheeling Hospital

Manish Monga
Ph: 304-293-2745
Email: sfilburn@hsc.wvu.edu

Wisconsin
Oshkosh

Vince Lombardi Cancer Clinic - Oshkosh

Zahid N Dar
Ph: 800-252-2990

Racine

All Saints Cancer Center at Wheaton Franciscan Healthcare

Young M Choi
Ph: 414-874-4541
Email: Kelli.holton@wfhc.org

See All Trial Sites

Link to the current ClinicalTrials.gov record.
NLM Identifier NCT00324805
ClinicalTrials.gov processed this data on May 25, 2015

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