Trial Search Results

Chemotherapy With or Without Bevacizumab in Patients With Completely Resected Stage IB-IIIA Non-small Cell Lung Cancer

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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

National Cancer Institute (NCI)

Collaborator: Southwest Oncology Group


  • Biological: Bevacizumab
  • Drug: Cisplatin
  • Drug: Docetaxel
  • Drug: Gemcitabine Hydrochloride
  • Drug: Pemetrexed Disodium
  • Drug: Vinorelbine


Phase 3


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

   - 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

   - 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

   - 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

   - 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 other 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 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:

      - 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

Exclusion Criteria:

   - 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

   - Having received any of the following:

      - Prior systemic chemotherapy at any time, but 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 and other low dose chemotherapeutics for
      non-malignant conditions will be considered, but review by the study chair is

      - 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)

   - Any history of cerebral vascular accident (CVA) or transient ischemic attack (TIA)

   - Women who are 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

   - 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

   - History of bleeding diathesis or coagulopathy

   - Treatment with dipyridamole (Persantine), ticlopine (Ticlid), clopidogrel (Plavix)
   and/or cilostazol (Pletal); patients must have stopped taking any of these agents at
   least 7 days prior to randomization

   - Serious non-healing wound, ulcer, bone fracture, or having 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

   - History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess
   within 28 days prior to randomization

   - Any anticipated major surgical procedure(s) during the course of the study

   - Known hypersensitivity to Chinese hamster ovary cell products or other recombinant
   human antibodies

   - Ongoing post-operative hemoptysis (defined as bright red blood of 1/2 teaspoon or

   - Squamous cell histology for patients who will receive pemetrexed (pemetrexed
   disodium)/cisplatin therapy

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study


Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Not Recruiting