Carboplatin, Paclitaxel, and Bevacizumab With or Without Erlotinib Hydrochloride in Treating Non-Smokers With Advanced Non-Small Cell Lung Cancer
Condition: Recurrent Non-small Cell Lung Cancer; Stage IIIB Non-small Cell Lung Cancer; Stage IV Non-small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: erlotinib hydrochloride; paclitaxel; carboplatin; bevacizumab
Intervention description: Given PO; Given IV; Given IV; Given IV
Intervention MeSH terms: Paclitaxel; Bevacizumab; Carboplatin; Erlotinib Hydrochloride; Antineoplastic Agents, Immunological; Antibodies; Immunoglobulins; Antibodies, Monoclonal
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This randomized phase II trial studies how well carboplatin, paclitaxel, and bevacizumab work
      with or without erlotinib hydrochloride in treating non-smokers with advanced non-small cell
      lung cancer. Drugs used in chemotherapy, such as carboplatin and paclitaxel, 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. Erlotinib hydrochloride
      may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and
      by blocking blood flow to the tumor. It is not yet known whether giving combination
      chemotherapy together with bevacizumab is more effective with or without erlotinib
      hydrochloride in treating patients with non-small cell lung cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Measurable disease as defined by Response Criteria In Solid Tumors (RECIST) criteria

          -  Baseline measurements and evaluations of all sites of disease must be obtained =< 4
             weeks (28 days) prior to randomization

          -  Eastern Cooperative Oncology Group (ECOG) performance status between 0-1

          -  No prior chemotherapy for lung cancer; prior chemotherapy for an unrelated condition
             is allowed if completed > 3 years prior to date of randomization

          -  Histological or cytologic evidence of non-small cell lung cancer

          -  Patients must not have any additional active, invasive malignancies requiring therapy

          -  Patients must have smoked less than or equal to 100 cigarettes in their lifetime

          -  Stage IV or IIIB (with pleural or pericardial effusion or multifocal pleural
             involvement) or recurrence after prior curative resection or definitive radiation

          -  Prior radiation therapy (RT) is allowed, provided RT has ended at least 2 weeks (14
             days) prior to date of randomization; patients must have recovered from any adverse
             events related to the RT (except alopecia and grade 1 neuropathy); no previous
             irradiation to the only site of measurable disease, unless that site has had
             subsequent evidence of pathologic or radiologic progression

          -  Absolute neutrophil count (ANC) >= 1500/mm^3

          -  Platelet count >= 100,000/mm^3

          -  Bilirubin =< 1.5 mg/dl

          -  Creatinine =< 2.0 mg/dl

          -  Serum glutamic oxaloacetic transaminase (SGOT) and serum glutamic pyruvate
             transaminase (SGPT) =< 3 X institutional upper limit of normal (ULN)

          -  Women must not be pregnant or breast-feeding due to unknown interaction between
             erlotinib and the developing fetus or newborns potentially exposed to erlotinib by
             ingestion of lactated milk; all females of childbearing potential must have a blood
             test within 2 weeks prior to randomization to rule out pregnancy

          -  Women of childbearing potential and sexually active males must be strongly advised to
             use an accepted and effective method of contraception

          -  Patients must not have clinically significant ongoing or active infection, symptomatic
             congestive heart failure, unstable angina pectoris, symptomatic or uncontrolled
             cardiac arrhythmia, or psychiatric illness/social situations that would limit
             compliance with study requirements

          -  Patient must meet the following criteria:

               -  Non-squamous histology

               -  No antecedent hemoptysis

               -  International normalized ratio (INR) =< 3 within 4 weeks (28 days) prior to
                  randomization

          -  Patients may be on a stable regimen of therapeutic anticoagulation or may be receiving
             prophylactic anticoagulation of venous access devices, provided that coagulation
             studies met entry criteria; 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 due to an increased
             risk of bleeding with bevacizumab

          -  No history of untreated brain metastases NOTE: Recent data (PASSPORT, ATLAS, AIRES)
             suggest that bevacizumab can be given in patients with treated brain metastases;
             investigators can use their discretion in deciding whether to use bevacizumab in
             patients who fulfill these criteria

          -  Urine dipstick must be =< 0-1+ within 4 weeks (28 days) of randomization. If urine
             dipstick is > 1+ then the Urine Protein Creatinine (UPC) ratio must be calculated

          -  Patients must have no history of thrombotic or hemorrhagic disorders

          -  Patients with history of hypertension must be well-controlled (blood pressure [BP] =<
             150/90 within 4 weeks [28 days] of randomization) and on a stable regimen of
             anti-hypertensive therapy (within 4 weeks of randomization)

          -  Patients must not have serious non-healing wound ulcer, bone fracture, or major
             surgical procedure within 28 days prior to randomization

          -  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 6 months prior to randomization

          -  Patients must not have a history of abdominal fistula, gastrointestinal perforation or
             intra-abdominal abscess within 6 months prior to randomization

          -  Patients must not have significant vascular disease (e.g., aortic aneurysm, requiring
             surgical repair or recent peripheral arterial thrombosis) within 6 months prior to
             randomization

          -  Patients must not have clinically significant cardiovascular disease including:

               -  History of cerebral vascular accident (CVA) within 6 months

               -  New York Heart Association grade II or greater congestive heart failure

               -  Serious and inadequately controlled cardiac arrhythmia

               -  Clinically significant peripheral vascular disease (symptomatic with intermittent
                  claudications or < 6 months from a bypass operation)