Multicenter Evaluation of Docetaxel, Gemcitabine, and Bevacizumab Combination Followed by Bevacizumab Alone in Subjects With Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Condition: Non-small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: docetaxel; gemcitabine; bevacizumab
Intervention MeSH terms: Bevacizumab; Gemcitabine; Docetaxel
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 17.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a Phase II prospective, multicenter study evaluating Progression Free Survival (PFS)
      after first line treatment with the combination of gemcitabine, docetaxel, and bevacizumab in
      subjects with advanced or metastatic Non-Small Cell Lung Cancer (NSCLC). PFS will be measured
      from the date of registration (ie, assignment of subject number when subject meets all entry
      criteria) to the earliest date of documented evidence of progressive disease, or the date of
      death due to any cause, whichever occurs first.
    

Eligibility criteria:

        The following information on clinical trials is provided for information purposes only to
        allow patients and physicians to have an initial discussion about the trial. This
        information is not intended to be complete information about the trial, to contain all
        considerations that may be relevant to potential participation in the trial, or to replace
        the advice of a personal physician or health professional.

        Inclusion Criteria:

          1. Histologic or cytologic confirmation of locally advanced (pleural effusion) or
             metastatic (Stage IIIB/IV) NSCLC (non-squamous-cell histology only), mixed tumor types
             can be selected based on predominant cell type unless small cell elements are
             discovered (in which case the subject is not eligible);

          2. Measurable disease, defined as at least one lesion that can be accurately measured in
             at least one dimension (longest diameter to be recorded) as >/= 20 mm with
             conventional computerized tomography (CT) or magnetic resonance imaging (MRI) scans,
             or as >/= 10 mm with spiral computerized tomography (CT) scan

          3. No previous systemic chemotherapy

          4. Estimated life expectancy of >/= 12 weeks

          5. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0, 1 or 2

          6. Nonpregnant, nonlactating female subjects; male and female subjects of childbearing
             potential must be willing to use an effective form of contraception while on therapy
             and for 90 days thereafter; an effective form of contraception is defined as an oral
             contraceptive or a double barrier method; pregnancy is to be determined/ ruled out
             through the use of serum human chorionic gonadotropin (HCG)

          7. Subjects must have adequate renal function as determined by the following within 1
             week prior to study registration: Calculated creatinine clearance >45 mL/min using
             Cockcroft-Gault formula; Urine protein: creatinine (UPC) ratio <1.0 by spot
             urinalysis; Urine dipstick for protein <2+ (subjects discovered to have >= 2+
             proteinuria on dipstick urinalysis at baseline should undergo a 24-hour urine
             collection and must demonstrate </= 1 g of protein in 24 hours to be eligible);

          8. Hematologic evaluation within 2 weeks prior to study registration (minimum values):
             Absolute neutrophil count (ANC) >/= 1500 mm3; Platelet count >/= 100,000 mm3;
             Hemoglobin (Hg) >/= 9.9 g/dL (erythropoietin may be transfused to maintain or exceed
             this level); Partial thromboplastin time (PTT) no greater than upper limit of normal
             (ULN)

          9. Hepatic function evaluation within 2 weeks prior to study registration (as detailed in
             protocol provided to Investigator): Total bilirubin </= upper limit of normal;
             Aspartate aminotransferase (AST), alanine aminotransferase (ALT) and alkaline
             phosphatase must be within the range allowing for eligibility; In determining
             eligibility the more abnormal of the two values (AST or ALT) should be used (details
             for decision in full protocol as provided to Investigator)

        Exclusion Criteria:

          1. Receipt of prior systemic chemotherapy, vascular endothelial growth factor (VEGF) or
             endothelial growth factor receptor (EGFR) inhibitor therapy at any time; receipt of
             recent or current radiation therapy; current, recent (within 4 weeks prior to study
             registration), or planned receipt of investigational therapy (investigational therapy
             is defined as treatment for which there is currently no regulatory authority approved
             indication)

          2. Subjects with cardiovascular diseases and related treatments

          3. Surgical procedure in anamnesis (medical history): Major surgical procedure, open
             biopsy, or significant traumatic injury within 28 days prior to registration, or
             anticipation of need for major surgical procedure during the course of the study;
             Minor surgical procedures (eg, fine needle aspirations, core biopsies) within 7 days
             prior to registration;

          4. Serious non-healing wound, ulcer, or bone fracture;

          5. History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess
             within 6 months prior to study registration;

          6. History of gross hemoptysis (defined as bright red blood of >/= 0.5 teaspoon)

          7. History of hypersensitivity reaction to drugs formulated with polysorbate 80;

          8. Subjects with brain metastases;

          9. Peripheral neuropathy >/= Grade 2 (based on Common Toxicity Criteria Adverse Event
             [CTCAE] v3.0);

         10. History of a malignancy other than NSCLC; exceptions to this include: Curatively
             treated basal cell carcinoma; cervical intraepithelial neoplasia; or localized
             prostate cancer with a current prostate-specific antigen (PSA) of <1.0 ng/dL on 2
             successive evaluations at least 3 months apart, and the most recent evaluation within
             4 weeks of study registration; History of another malignancy that was curatively
             treated and no evidence of disease for a minimum of 5 years;

         11. Symptoms of a clinically meaningful illness in the 90 days before the study, or
             history of other disease, (such as human immunodeficiency virus (HIV) positive,
             chronic infection (eg, pulmonary tuberculosis), or hepatitis A, B or C (active or
             previously treated), active infection with fever, metabolic dysfunction, physical
             examination finding, or clinical laboratory finding giving reasonable suspicion of a
             disease or condition that contraindicates the use of an investigational drug, that
             might affect the interpretation of the results of the study, or render the subject at
             high risk from treatment complications; (testing for these conditions will be at
             investigator discretion)

         12. Mental condition rendering the subject unable to understand the nature, scope, and
             possible consequences of the study