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A Phase II Multicenter Study of Docetaxel and Oxaliplatin in Combination With Bevacizumab as First-Line Treatment in Chemotherapy-Naïve Subjects With Unresectable Locally Advanced and/or Recurrent (Stage IIIB) or Metastatic (Stage IV) Non-Squamous Cell Histology Non-Small Cell Lung Cancer (NSCLC)

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

Thank you

Trial Information

A Phase II Multicenter Study of Docetaxel and Oxaliplatin in Combination With Bevacizumab as First-Line Treatment in Chemotherapy-Naïve Subjects With Unresectable Locally Advanced and/or Recurrent (Stage IIIB) or Metastatic (Stage IV) Non-Squamous Cell Histology Non-Small Cell Lung Cancer (NSCLC)

The planned treatment duration for each participant is six 21-day treatment cycles of
combination therapy; non-progressing participants will continue on bevacizumab monotherapy
until progression. After discontinuation or after completion of all study treatments, all
participants will be contacted every 3 months for a maximum of 2 years from first treatment
to document overall survival and record new anticancer treatment (chemotherapy or biologic).

Inclusion Criteria

Inclusion Criteria

Participants who met all of the following criteria during screening were considered for
enrollment into the study:

1. Had the informed consent in writing for all prior to registration into the study

2. Had histologic or cytologic confirmation of locally advanced or metastatic (stage
IIIb/IV) NSCLC (non-squamous histology). Participants with mixed tumor types could
have been enrolled, unless small cell elements were discovered

3. Had measurable disease, defined as at least 1 lesion that could be accurately
measured in at least 1 dimension (longest diameter) as ≥ 2.0 cm with conventional
computerized tomography (CT) or magnetic resonance imaging (MRI) scans, or as ≥ 1.0
cm with spiral CT scan

4. Had no prior systemic chemotherapy

5. Was male or female ≥ 18 years old

6. Had an estimated life expectance of ≥ 12 weeks

7. Had an ECOG performance status (PS) of 0, 1, or 2

8. Was a nonpregnant, nonlactating female Was a male or female of childbearing potential
who was willing to use an effective form of contraception while on therapy and for 90
days thereafter.

9. Had adequate renal function as determined by the following within 2 weeks prior to
study registration.

- A calculated creatinine clearance greater than 45 mL/min using the
Cockcroft-Gault formula

- A urine dipstick or urinalysis for protein <2+ (Participants discovered to have
≥ 2+ proteinuria on dipstick or urinalysis at baseline had to undergo a 24 hour
urine collection and had to have ≤ 1 gm of protein over 24 hours to be

10. Had a hematologic evaluation within 2 weeks prior to study registration (and met the
minimum values):

- Had absolute neutrophil count (ANC) ≥ 1,500 cells/microL

- Had platelet count ≥ 100,000 cells/microL

- Had hemoglobin ≥ 9.9 gm/deciL (erythropoietin [e.g., Epogen®] could have been
used to maintain or exceed this level)

- Had a partial thromboplastin time (PTT) ≤ upper limit of normal (ULN)

11. Had a hepatic function evaluation within 2 weeks prior to study registration met the
eligibility criteria for bilirubin, Aspartate aminotransferase (AST), alanine
aminotransferase (ALT), and alkaline phosphatase.

Exclusion criteria

Participants with any of the following were not included in the study:

1. Had received prior systemic chemotherapy or vascular endothelial growth factor (VEGF)
or epidermal growth factor receptor (EGFR) inhibitor therapy at any time; or had
received recent or current radiation therapy

2. Had intrathoracic lung carcinoma of squamous cell histology. (Participants with
extrathoracic-only squamous cell NSCLC were eligible. Participants with only
peripheral lung lesions (of any NSCLC histology) were also eligible

3. Had cardiovascular diseases and related treatment, including the following:

- New York Heart Association Class ≥ 2 congestive heart failure; participants with
a history of serious cardiac disease not adequately controlled; or a history of
myocardial infarction or unstable angina pectoris within 6 months prior to study

- History of stroke or transient ischemic attack within 6 months of study

- History of hypertensive crisis or hypertensive encephalopathy

- History of thrombotic or hemorrhagic disease

- Evidence of bleeding diathesis or coagulopathy (in the absence of therapeutic

- Clinically meaningful peripheral vascular disease, or arrhythmia

- Inadequately controlled blood pressure (defined as systolic blood pressure >150
mm Hg and/or diastolic blood pressure >100 mm Hg)

- Significant vascular disease (e.g., aortic aneurysm, aortic dissection) within 6
months prior to study registration

- Therapeutic anticoagulation (Participants receiving prophylactic anticoagulation
for venous access devices were allowed providing they met certain criteria)

- Chronic daily treatment with aspirin (≥ 325 mg/day) or nonsteroidal
anti-inflammatory agents known to inhibit platelet function; treatment with
dipyridamole, ticlopidine, clopidogrel, or cilostazol was not allowed.

4. Had a surgical procedure in anamnesis (medical history):

- Major surgical procedure, open biopsy, or significant traumatic injury within 4
weeks prior to study registration, or anticipation of need for major surgical
procedure during the course of the study

- In the case of high-risk procedures, such as liver resection, thoracotomy, or
neurosurgery, within 8 weeks prior to study registration

- Minor surgical procedures (e.g., fine needle aspirations, core biopsies) within
7 days prior to registration

5. Had a serious nonhealing wound, active ulcer, or untreated bone fracture

6. Had a history of abdominal fistula, gastrointestinal perforation, or intra-abdominal
abscess within 6 months prior to study registration

7. Had a history of gross hemoptysis (defined as bright red blood of ≥ 0.5 teaspoon)
within 4 weeks prior to study registration

8. Had a history of hypersensitivity reaction to drugs formulated with polysorbate 80 or
platinum containing compounds

9. Had peripheral neuropathy ≥ Grade 2 (based on CTCAE v3.0)

10. Had known central nervous system (CNS) disease, except for treated brain metastasis.
However, participants with CNS metastases treated by neurosurgical resection or brain
biopsy performed within 3 months prior to study registration were excluded.

11. Had a history of a malignancy other than NSCLC; exceptions to this included:

- Curatively treated basal cell carcinoma, cervical intraepithelial neoplasia, or
localized prostate cancer with a current prostate-specific antigen (PSA) of less
than 1.0 ng/dL on 2 successive evaluations at least 3 months apart, and the most
recent evaluation being 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

12. Had symptoms of a clinically meaningful illness in the 90 days before study
registration, or had history of other disease, (such as human immunodeficiency virus
[HIV] positive, chronic infection [e.g., pulmonary tuberculosis], or hepatitis A, B,
or C [active or previously treated]), had an active infection with fever, had
metabolic dysfunction, had physical examination finding, or had clinical a laboratory
finding giving reasonable suspicion of a disease or condition that contraindicated
the use of an investigational drug, that might affect the interpretation of the
results of the study, or render the participant at high risk from treatment
complications; (testing for these conditions was at investigator discretion)

13. Had a mental condition rendering the participant unable to understand the nature,
scope, and possible consequences of the study

The above information is not intended to contain all considerations relevant to a patients
potential participation in a clinical trial.

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 (PFS)

Outcome Description:

PFS was defined as the interval from the date of registration to the earliest date of documented evidence of progressive disease, or the date of death due to any cause, whichever occurred first. Progressive disease occurred when the participant had at least a 20% increase in the sum of the longest diameter (LD) of target lesions, compared to the smallest sum LD recorded since the treatment started, or the appearance of 1 or more new lesions.

Outcome Time Frame:

Baseline to PFS (up to 24 months after the first treatment)

Safety Issue:


Principal Investigator

Vicki Erickson, MSN

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

July 2006

Completion Date:

August 2010

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Lung
  • non-small cell
  • chemotherapy
  • tumor
  • advanced
  • recurrent
  • metastatic
  • Non-Small Cell Lung Cancer (NSCLC)
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



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