Trial Search Results

Bevacizumab or Pemetrexed Disodium Alone or In Combination After Induction Therapy in Treating Patients With Advanced Non-Squamous Non-Small Cell Lung Cancer

The purpose of this study is to find out the best maintenance therapy for patients with advanced stage non-small cell lung cancer. Maintenance therapy is usually given after 4 cycles of standard chemotherapy (1 cycle = 21 days) to keep the disease under control for a longer duration. This study will compare the effects, good and/or bad, of bevacizumab, pemetrexed or the combination of the two agents when given as maintenance therapy.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Eastern Cooperative Oncology Group

Collaborator: National Cancer Institute (NCI)

Stanford Investigator(s):


  • Biological: bevacizumab
  • Drug: pemetrexed disodium


Phase 3



   - Cytologically or histologically confirmed non-small cell lung cancer (NSCLC)

      - Predominant non-squamous histology

         - NSCLC not otherwise specified allowed

         - Mixed tumors are categorized by the predominant cell type

   - Must meet 1 of the following criteria:

      - Stage IV disease including M1a or M1b stages or recurrent disease

      - Stage IIIB (T4NX) disease with ipsilateral lung lobe allowed provided patients
      are not candidates for combined chemotherapy or radiotherapy

   - Measurable or non-measurable disease as defined by RECIST criteria

   - Patient must have an overall stable or better response after 4 courses of induction

   - No cavitary lesions in the lungs

   - Patients with brain metastasis must have received local therapy to the brain and have
   no evidence of progression in the brain for at least 2 weeks from the time of
   completion of local therapy, prior to registration


   - ECOG performance status 0-1

   - Leukocytes ≥ 3,000/mm^3

   - ANC ≥ 1,500/mm^3

   - Platelet count ≥ 100,000/mm^3

   - Total bilirubin ≤ institutional upper limit of normal (ULN)

   - AST and ALT ≤ 3 times ULN

   - Creatinine ≤ institutional ULN OR creatinine clearance ≥ 60 mL/min

   - Urine protein:urine dipstick ≤ 0-1+ (if > 1+, urine protein creatinine ratio must be <

   - Not pregnant or nursing

   - Negative pregnancy test

   - Fertile patients must agree to abstain from sexual intercourse or to use adequate
   contraceptive methods during and for at least 6 months after completion of study

   - No prior malignancy within the past 3 years except superficial melanoma, basal cell
   carcinoma, or carcinoma in situ

   - No major hemoptysis within the past 4 weeks

   - No uncontrolled intercurrent illness including, but not limited to, any of the

      - Ongoing or active infection

      - Symptomatic congestive heart failure

      - Unstable angina pectoris

      - Serious cardiac arrhythmia

      - Psychiatric illness and/or social situations that would limit compliance with
      study requirements

   - Patients with hypertension must be adequately controlled (BP < 150/100 mm Hg) with
   appropriate anti-hypertensive therapy or diet

   - No history of arterial thrombotic events or major bleeding within the past 12 months

   - No significant vascular disease (e.g., aortic aneurysm requiring surgical repair or
   recent peripheral arterial thrombosis) within the past 6 months

   - No significant traumatic injury in the past 3 months

   - No clinically significant cardiovascular disease

   - No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within
   the past 6 months

   - No history of serious non-healing wounds, ulcers, or bone fractures


   - See Disease Characteristics

   - At least 12 months since prior adjuvant chemotherapy

   - At least 2 weeks since prior radiotherapy

   - Patients must not have had any major surgery such as thoracotomy, laparotomy,
   craniotomy, or significant traumatic injury within 6 weeks prior to registration

      - Biopsy procedures and chest tube insertion are not considered major surgery for
      the purpose of this protocol

   - More than 7 days since a core biopsy

   - Concurrent therapeutic anti-coagulation allowed

   - No prior systemic chemotherapy for advanced stage lung cancer

   - No prior paclitaxel, pemetrexed disodium, or bevacizumab

      - Prior carboplatin allowed provided it was given as part of adjuvant chemotherapy

   - No concurrent anti-retroviral therapy in patients with HIV infection

Ages Eligible for Study

18 Years - 120 Years

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