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A Phase II, Multicenter Evaluation of Docetaxel, Gemcitabine, and Bevacizumab Combination Followed by Bevacizumab Alone in Subjects With Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Phase 2
18 Years
Not Enrolling
Non-small Cell Lung Cancer

Thank you

Trial Information

A Phase II, Multicenter Evaluation of Docetaxel, Gemcitabine, and Bevacizumab Combination Followed by Bevacizumab Alone in Subjects With Locally Advanced or Metastatic Non-Small Cell Lung Cancer

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
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

9. Hepatic function evaluation within 2 weeks prior to study registration (as detailed
in protocol provided to Investigator): Total bilirubin 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

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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression Free Survival for Subjects With Locally Advanced or Metastatic (Stage IIIB or Stage IV) Non-Small Cell Lung Cancer (NSCLC) After Systemic Treatment With Gemcitabine, Docetaxel, and Bevacizumab as First Line Therapy

Outcome Time Frame:

1 year post-registration

Safety Issue:


Principal Investigator

Phyllis Diener, BS, MT (ASCP)

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

January 2007

Completion Date:

September 2008

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



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