Bevacizumab, Docetaxel, and Gemcitabine Patients With Stage IIIB, Stage IV, or Recurrent Non-Small Cell Lung Cancer
Condition: Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: bevacizumab; docetaxel; gemcitabine hydrochloride
Intervention description: 15 mg/kg on day 1 of a 21-day cycle; 75 mg/m2 on day 1; 900 mg/m2 on days 1, and 8,
Intervention MeSH terms: Bevacizumab; Gemcitabine; Docetaxel
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 13.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: recurrent non-small cell lung cancer; stage IIIB non-small cell lung cancer; stage IV non-small cell lung cancer; adenocarcinoma of the lung; bronchoalveolar cell lung cancer; large cell lung cancer

Summary:

      RATIONALE: 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. Drugs used in chemotherapy, such as
      docetaxel and gemcitabine hydrochloride, work in different ways to stop the growth of tumor
      cells, either by killing the cells or by stopping them from dividing. Giving bevacizumab
      together with docetaxel and gemcitabine hydrochloride may kill more tumor cells.

      PURPOSE: This phase II trial is studying how well giving bevacizumab together with docetaxel
      and gemcitabine hydrochloride works in treating patients with stage IIIB, stage IV, or
      recurrent non-small cell lung cancer.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed non-squamous cell non-small cell lung cancer

               -  Stage IIIB (with pleural effusion), stage IV, or recurrent disease

          -  Bidimensionally measurable disease

          -  No known CNS disease, except for previously treated brain metastasis defined as no
             evidence of progression or hemorrhage after treatment AND no ongoing requirement for
             dexamethasone as documented by clinical examination, MRI, or CT scan

               -  Treatment for brain metastases may have included whole brain radiotherapy,
                  radiosurgery (gamma knife, LINAC, or equivalent), or a combination of therapy as
                  deemed appropriate by the treating physician

               -  Stable dose of anticonvulsants allowed

          -  No known metastatic disease to the gastrointestinal tract (e.g., stomach, small bowel,
             or large bowel)

        PATIENT CHARACTERISTICS:

          -  ECOG performance status 0-1

          -  Life expectancy > 3 months

          -  ANC ≥ 1,500/mm^3

          -  Platelet count ≥ 100,000/mm^3

          -  Hemoglobin ≥ 9 g/dL

          -  Bilirubin ≤ 2.0 mg/dL

          -  AST or ALT ≤ 2.5 times upper limit of normal (ULN) (≤ 5.0 times ULN if hepatic
             metastases are present)

          -  Serum creatinine ≤ 1.8 mg/dL

          -  Urine protein:creatinine ratio < 1.0 OR proteinuria < 2+ by urine dipstick OR ≤ 1 g of
             protein by 24-hour urine collection

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  Available for regular follow-ups

          -  No inadequately controlled hypertension, defined as systolic BP > 150 mm Hg and/or
             diastolic BP > 100 mm Hg despite antihypertensive medications

          -  No history of hypertensive crisis or hypertensive encephalopathy

          -  No NYHA class II-IV congestive heart failure

          -  No myocardial infarction or unstable angina within the past 6 months

          -  No stroke or transient ischemic attack within the past 6 months

          -  No significant vascular disease (e.g., aortic aneurysm, aortic dissection requiring
             surgical repair, or recent peripheral arterial thrombosis) within the past 6 months

          -  No symptomatic peripheral vascular disease

          -  No evidence of bleeding diathesis or coagulopathy (in the absence of therapeutic
             anticoagulation)

          -  No history of colonic diverticular disease (i.e., diverticulosis or diverticulitis)

          -  No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within
             the past 6 months

          -  No serious, nonhealing wound, ulcer, or bone fracture

          -  No known hypersensitivity to any component of bevacizumab

          -  No hemoptysis (bright red blood of ≥ ½ teaspoon per episode) within the past 3 months

          -  No significant traumatic injury within the past 28 days

        PRIOR CONCURRENT THERAPY:

          -  See Disease Characteristics

          -  No prior chemotherapy or biological therapy

          -  No prior radiotherapy to an area of measurable disease unless there is documented
             progressive disease after completion of therapy

          -  More than 2 weeks since prior radiotherapy

          -  More than 4 weeks since prior and no concurrent participation in another experimental
             drug study, except for a Genentech-sponsored bevacizumab cancer study

          -  More than 28 days since prior major surgical procedure or open biopsy

          -  More than 3 months since prior abdominal surgery

          -  More than 3 months since prior neurosurgical resection or brain biopsy

          -  More than 7 days since prior core biopsy or other minor surgical procedure, except
             placement of a vascular access device

          -  No concurrent major surgical procedure