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Summary

for people ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started

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.

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)

Details

PRIMARY OBJECTIVES:

  1. 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:

  1. 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.

Keywords

Stage IB Non-Small Cell Lung Carcinoma AJCC v7 Stage IIA Non-Small Cell Lung Carcinoma AJCC v7 Stage IIB Non-Small Cell Lung Carcinoma AJCC v7 Stage IIIA Non-Small Cell Lung Cancer AJCC v7 Carcinoma Lung Neoplasms Carcinoma, Non-Small-Cell Lung Gemcitabine Docetaxel Vinorelbine Cisplatin Bevacizumab Pemetrexed Vinblastine Antibodies Immunoglobulins Antibodies, Monoclonal Immunoglobulin G Endothelial Growth Factors

Eligibility

For people ages 18 years and up

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 mm3

  • Platelets >= 100,000/mm3

  • 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

  • Zuckerberg San Francisco General Hospital
    San Francisco, California, 94110, United States
  • UCSF Medical Center-Mount Zion
    San Francisco, California, 94115, United States
  • California Pacific Medical Center-Pacific Campus
    San Francisco, California, 94115, United States
  • Kaiser Permanente-San Francisco
    San Francisco, California, 94115, United States
  • California Cancer Center - North Fresno
    Fresno, California, 93720, United States
  • Cancer Care Associates of Fresno Medical Group Inc
    Fresno, California, 93720, United States
  • Kaiser Permanente
    Fresno, California, 93720, United States
  • Kaiser Permanente Cancer Treatment Center
    South San Francisco, California, 94080, United States
  • Kaiser Permanente-South San Francisco
    South San Francisco, California, 94080, United States
  • Bay Area Breast Surgeons Inc
    Emeryville, California, 94608, United States
  • Epic Care Partners in Cancer Care
    Emeryville, California, 94608, United States
  • Alta Bates Summit Medical Center - Summit Campus
    Oakland, California, 94609, United States
  • Bay Area Tumor Institute
    Oakland, California, 94609, United States
  • Hematology and Oncology Associates-Oakland
    Oakland, California, 94609, United States
  • Tom K Lee Inc
    Oakland, California, 94609, United States
  • Alta Bates Summit Medical Center-Herrick Campus
    Berkeley, California, 94704, United States
  • Marin Cancer Care Inc
    Greenbrae, California, 94904, United States
  • Marin General Hospital
    Greenbrae, California, 94904, United States
  • Highland General Hospital
    Oakland, California, 94602, United States
  • Kaiser Permanente-Richmond
    Richmond, California, 94801, United States
  • Mills-Peninsula Medical Center
    Burlingame, California, 94010, United States
  • Kaiser Permanente Oakland-Broadway
    Oakland, California, 94611, United States
  • Kaiser Permanente-Oakland
    Oakland, California, 94611, United States
  • Doctors Medical Center- JC Robinson Regional Cancer Center
    San Pablo, California, 94806, United States
  • Kaiser Permanente San Leandro
    San Leandro, California, 94577, United States
  • Kaiser Permanente-San Rafael
    San Rafael, California, 94903, United States
  • East Bay Radiation Oncology Center
    Castro Valley, California, 94546, United States
  • Eden Hospital Medical Center
    Castro Valley, California, 94546, United States
  • Valley Medical Oncology Consultants-Castro Valley
    Castro Valley, California, 94546, United States
  • Saint Rose Hospital
    Hayward, California, 94545, United States
  • Contra Costa Regional Medical Center
    Martinez, California, 94553-3156, United States
  • Kaiser Permanente-Redwood City
    Redwood City, California, 94063, United States
  • Kaiser Permanente-Walnut Creek
    Walnut Creek, California, 94596, United States
  • Sutter Cancer Research Consortium
    Novato, California, 94945, United States
  • Palo Alto Medical Foundation Health Care
    Palo Alto, California, 94301, United States
  • Stanford Cancer Institute
    Palo Alto, California, 94304, United States
  • Kaiser Permanente-Vallejo
    Vallejo, California, 94589, United States
  • Sutter Solano Medical Center/Cancer Center
    Vallejo, California, 94589, United States
  • Kaiser Permanente-Fremont
    Fremont, California, 94538, United States
  • Valley Medical Oncology Consultants-Fremont
    Fremont, California, 94538, United States
  • Valley Care Health System - Pleasanton
    Pleasanton, California, 94588, United States
  • Valley Medical Oncology Consultants
    Pleasanton, California, 94588, United States
  • El Camino Hospital
    Mountain View, California, 94040, United States
  • Palo Alto Medical Foundation-Camino Division
    Mountain View, California, 94040, United States
  • Palo Alto Medical Foundation-Sunnyvale
    Sunnyvale, California, 94086, United States
  • Kaiser Permanente Medical Center - Santa Clara
    Santa Clara, California, 95051, United States
  • Kaiser Permanente-Deer Valley Medical Center
    Antioch, California, 94531, United States
  • Rohnert Park Cancer Center
    Rohnert Park, California, 94928, United States
  • Northbay Cancer Center
    Vacaville, California, 95687, United States
  • Kaiser Permanente Medical Center-Vacaville
    Vacaville, California, 95688, United States
  • Kaiser Permanente-Santa Teresa-San Jose
    San Jose, California, 95119, United States
  • Kaiser Permanente-Santa Rosa
    Santa Rosa, California, 95403, United States
  • Sutter Pacific Medical Foundation
    Santa Rosa, California, 95403, United States
  • Mercy UC Davis Cancer Center
    Merced, California, 95340, United States
  • Kaiser Permanente-Stockton
    Stockton, California, 95210, United States
  • Kaiser Permanente-South Sacramento
    Sacramento, California, 95823, United States
  • South Sacramento Cancer Center
    Sacramento, California, 95823, United States
  • University of California Davis Comprehensive Cancer Center
    Sacramento, California, 95817, United States
  • Sutter Medical Center Sacramento
    Sacramento, California, 95816, United States
  • Kaiser Permanente-Modesto
    Modesto, California, 95356, United States
  • Kaiser Permanente - Sacramento
    Sacramento, California, 95825, United States
  • Memorial Medical Center
    Modesto, California, 95355, United States
  • Kaiser Permanente-Rancho Cordova Cancer Center
    Rancho Cordova, California, 95670, United States
  • Community Hospital of Monterey Peninsula
    Monterey, California, 93940, United States
  • The Permanente Medical Group-Roseville Radiation Oncology
    Roseville, California, 95678, United States
  • Kaiser Permanente-Roseville
    Roseville, California, 95661, United States
  • Sutter Roseville Medical Center
    Roseville, California, 95661, United States
  • Fremont - Rideout Cancer Center
    Marysville, California, 95901, United States
  • PCR Oncology
    Pismo Beach, California, 93449, United States
  • Gene Upshaw Memorial Tahoe Forest Cancer Center
    Truckee, California, 96161, United States
  • Renown Regional Medical Center
    Reno, Nevada, 89502, United States
  • Kaiser Permanente - Panorama City
    Panorama City, California, 91402, United States
  • Kaiser Permanente
    Woodland Hills, California, 91367, United States
  • Providence Saint Joseph Medical Center/Disney Family Cancer Center
    Burbank, California, 91505, United States
  • Glendale Memorial Hospital and Health Center
    Glendale, California, 91204, United States
  • Kaiser Permanente Los Angeles Medical Center
    Los Angeles, California, 90027, United States
  • Kaiser Permanente-Cadillac
    Los Angeles, California, 90034, United States
  • Los Angeles County-USC Medical Center
    Los Angeles, California, 90033, United States
  • USC / Norris Comprehensive Cancer Center
    Los Angeles, California, 90033, United States
  • City of Hope Comprehensive Cancer Center
    Duarte, California, 91010, United States
  • Kaiser Permanente-Baldwin Park
    Baldwin Park, California, 91706, United States
  • Pomona Valley Hospital Medical Center
    Pomona, California, 91767, United States
  • Kaiser Permanente-Bellflower
    Bellflower, California, 90706, United States
  • Kaiser Permanente - Harbor City
    Harbor City, California, 90710, United States
  • Saint Jude Medical Center
    Fullerton, California, 92835, United States
  • Kaiser Permanente Hospital
    Fontana, California, 92335, United States
  • Kaiser Permanente-Anaheim
    Anaheim, California, 92807, United States
  • Saint Joseph Hospital - Orange
    Orange, California, 92868, United States
  • UC Irvine Health/Chao Family Comprehensive Cancer Center
    Orange, California, 92868, United States
  • Kaiser Permanente-Riverside
    Riverside, California, 92505, United States
  • Kaiser Permanente-Irvine
    Irvine, California, 92618, United States
  • Nevada Cancer Institute-Summerlin Campus
    Las Vegas, Nevada, 89135, United States
  • University Medical Center of Southern Nevada
    Las Vegas, Nevada, 89102, United States
  • Nevada Cancer Research Foundation CCOP
    Las Vegas, Nevada, 89106, United States
  • Eisenhower Medical Center
    Rancho Mirage, California, 92270, United States
  • Kaiser Permanente-San Marcos
    San Marcos, California, 92069, United States

Details

Status
in progress, not accepting new patients
Start Date
Sponsor
National Cancer Institute (NCI)
ID
NCT00324805
Phase
Phase 3
Study Type
Interventional
Last Updated
July 25, 2017