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

Not Recruiting

Trial ID: NCT00324805


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)

Stanford Investigator(s)

Heather Wakelee
Heather Wakelee

Winston Chen and Phyllis Huang Professor

Joel Neal, MD, PhD
Joel Neal, MD, PhD

Associate Professor of Medicine (Oncology)

Harlan Pinto
Harlan Pinto

Associate Professor of Medicine (Oncology) and of Otolaryngology - Head & Neck Surgery


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

   - 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

   - 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

      - 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


drug: cisplatin

drug: docetaxel

drug: gemcitabine hydrochloride

drug: pemetrexed disodium

biological: bevacizumab

other: Laboratory Biomarker Analysis

other: Questionnaire Administration

drug: Vinorelbine Tartrate

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305

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