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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 Lung Cancer That Was Removed By Surgery

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

Basic Trial Information

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

Trial Description

Summary

This randomized phase III trial is studying 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 or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab also may stop the growth of tumor cells by blocking blood flow to the tumor. Giving chemotherapy together with bevacizumab after surgery may kill any tumor cells that remain after surgery. 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. Compare overall survival of patients with completely resected stage IB (tumors ≥ 4cm)-IIIA non-small cell lung cancer treated with adjuvant chemotherapy with or without bevacizumab.

SECONDARY OBJECTIVES:

I. Compare disease-free survival of patients treated with these regimens. II. Compare the toxicity of these regimens in these patients. III. Perform analyses of tissue and blood to establish factors that predict clinical outcome in patients treated with these regimens.

IV. Determine whether smoking status is linked to outcome in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to type of chemotherapy (cisplatin/vinorelbine ditartrate vs cisplatin/docetaxel vs cisplatin/gemcitabine hydrochloride vs cisplatin/pemetrexed disodium), stage (IB vs II vs IIIA [N2] vs IIIA [T3, N1]), histology (squamous cell vs other), and gender. 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 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. Patients complete smoking status questionnaires at baseline and then every 3 months during study treatment.

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

Eligibility Criteria

Inclusion Criteria:

  • Diagnosis of stage IB-IIIA (T2-3 N0, T1-3 N1, T1-3 N3) non-small cell lung cancer (NSCLC)
  • Patients with stage IB disease must have tumors measuring ≥ 4 cm
  • No non-squamous cell histology (for patient assigned to receive the pemetrexed disodium and cisplatin therapy)
  • Must have undergone complete resection of NSCLC within the past 6-12 weeks
  • Accepted types of resection include any of the following:
  • Lobectomy
  • Sleeve lobectomy
  • Bilobectomy
  • Pneumonectomy
  • No resection by segmentectomy or wedge resection
  • Mediastinal lymph node sampling at specific levels is required pre-operatively (mediastinoscopy) or intraoperatively (level 7 for right-sided tumors or level 7 and 5 and/or 6 for left sided tumors)
  • ECOG performance status 0-1
  • Absolute neutrophil count ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • INR ≤ 1.5 OR INR ≤ 3.0 with therapeutic anticoagulation
  • PTT normal OR PTT ≤ 1.5 times upper limit of normal (ULN) for patients on therapeutic anticoagulation
  • Bilirubin ≤ 1.5 mg/dL
  • AST and ALT < 5 times ULN
  • Creatinine ≤ 1.5 times ULN
  • Creatinine clearance ≥ 45 mL/min (for patient assigned to receive the pemetrexed disodium and cisplatin therapy)
  • If urine protein: creatinine ratio > 0.5, then urine protein must be < 1,000 mg by 24-hour urine collection
  • No other cancer within the past 5 years except in situ carcinoma of the cervix or completely resected nonmelanoma skin cancer
  • Known history of myocardial infarction or other evidence of arterial thrombotic disease (angina) allowed if there is no evidence of active disease within the past 12 months
  • No history of cerebrovascular accident or transient ischemic attack
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for at least 6 months after completion of study treatment
  • No clinically significant ongoing, active, or serious infection, symptomatic or uncontrolled congestive heart failure or cardiac arrhythmia, psychiatric illness or social situation, or any other medical condition that would preclude study compliance
  • No history of bleeding diathesis or coagulopathy
  • Systolic blood pressure (BP) ≤ 150 and diastolic BP ≤ 90 within the past 28days
  • Patients with known hypertension on a stable regimen of antihypertensive therapy allowed
  • No serious nonhealing wound, ulcer, or bone fracture
  • No significant traumatic injury within the past 28 days
  • No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 28 days
  • No known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies
  • No ongoing postoperative hemoptysis (i.e., bright red blood of ≥ ½ teaspoon
  • Recovered from prior surgery
  • At least 7 days since prior aspirin or non-steroidal anti-inflammatory agents (NSAIDS), dipyridamole (Persantine), ticlopine (Ticlid),clopidogrel (Plavix) and/or cilostazol (Pletal)
  • No prior systemic chemotherapy
  • Prior methotrexate given in low doses for non-malignant conditions with the last dose ≥ 2 weeks ago is allowed
  • Other low-dose chemotherapeutics for non-malignant conditions may be allowed after review by the study chair
  • No hormonal cancer therapy or radiotherapy as cancer treatment within the past 5years
  • Prior surgery, biologic therapy, hormonal therapy, or radiotherapy for a malignancy diagnosed > 5 years prior to study entry that is now considered cured allowed
  • No major surgery or open biopsy within the past 28 days
  • No anticipated major surgery during course of treatment
  • No core biopsy within the past 7 days
  • Concurrent therapeutic anticoagulation therapy allowed
  • No concurrent aminoglycoside antibiotics
  • No concurrent growth factors

Trial Contact Information

Trial Lead Organizations/Sponsors

National Cancer Institute

Southwest Oncology Group (SWOG) Research Base

North Central Cancer Treatment Group

Cancer and Leukemia Group B

NCIC-Clinical Trials Group

Heather WakeleePrincipal 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

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00324805
ClinicalTrials.gov processed this data on March 26, 2014

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.