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

Not Recruiting

Trial ID: NCT01107626


RATIONALE: Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. 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 may also stop the growth of non-small cell lung cancer by blocking blood flow to the tumor. Pemetrexed disodium may stop the growth of tumor cells by blocking some enzymes needed for cell growth. It is not yet known whether giving bevacizumab or pemetrexed disodium alone or in combination is more effective in treating non-squamous non-small cell lung cancer. PURPOSE: This randomized phase III trial is studying bevacizumab and pemetrexed disodium alone or in combination after induction therapy to see how well they work in treating patients with advanced non-squamous non-small cell lung cancer.

Official Title

Randomized Phase III Study of Maintenance Therapy With Bevacizumab, Pemetrexed, or a Combination of Bevacizumab and Pemetrexed Following Carboplatin, Paclitaxel and Bevacizumab for Advanced Non-Squamous 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)


Inclusion Criteria (Step 1 Induction Therapy):

   - 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.

   - 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

   - At least 12 months since prior adjuvant chemotherapy

   - At least 2 weeks since prior radiotherapy

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

   - 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 (Eastern Cooperative Oncology Group) performance status 0-1

   - Leukocytes ≥ 3,000/mm^3

   - Absolute neutrophil count ≥ 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 <

   - Measurable or non-measurable disease as defined by RECIST (Response Evaluation
   Criteria in Solid Tumours) criteria

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

   - Concurrent therapeutic anti-coagulation allowed

   - 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

Exclusion Criteria (Step 1 Induction Therapy):

   - Prior malignancy within the past 3 years except superficial melanoma, basal cell
   carcinoma, or carcinoma in situ

   - Prior systemic chemotherapy for advanced stage lung cancer

   - Prior use of paclitaxel, pemetrexed disodium, or bevacizumab

   - Major hemoptysis within the past 4 weeks

   - Uncontrolled intercurrent illness including, but not limited to, active infection,
   symptomatic congestive heart failure, unstable angina pectoris, serious cardiac
   arrhythmia, psychiatric illness/social situations that would limit compliance with
   study requirements

   - History of arterial thrombotic events or major bleeding within the past 12 months

   - 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.

   - Core biopsy within 7 days of registration

   - Significant vascular disease (e.g., aortic aneurysm requiring surgical repair or
   recent peripheral arterial thrombosis) within the past 6 months

   - Clinically significant cardiovascular disease

   - Abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the
   past 6 months

   - History of serious non-healing wounds, ulcers, or bone fractures

   - Cavitary lesions in the lungs

   - Pregnant or nursing

   - Concurrent anti-retroviral therapy in patients with HIV infection

Inclusion Criteria (Step 2 Maintenance Therapy):

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

   - ECOG (Eastern Cooperative Oncology Group) performance status 0-1

   - Patients must be registered to Step 2 within 6 weeks of the last day of chemotherapy
   administration on Step 1

   - Acceptable bone marrow, renal and hepatic function within 2 weeks of registration


biological: bevacizumab

drug: Paclitaxel

drug: Carboplatin

drug: Pemetrexed Disodium Heptahydrate

Not Recruiting

Contact Information

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

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