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Evaluation of Avastin and Weekly Docetaxel in Elderly (>= 75 Years) Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)

Phase 2
75 Years
Open (Enrolling)
Adenocarcinoma of the Lung, Bronchoalveolar Cell Lung Cancer, Large Cell Lung Cancer, Recurrent Non-small Cell Lung Cancer, Stage IIIA Non-small Cell Lung Cancer, Stage IIIB Non-small Cell Lung Cancer, Stage IV Non-small Cell Lung Cancer

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Trial Information

Evaluation of Avastin and Weekly Docetaxel in Elderly (>= 75 Years) Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)


I. To determine the proportion of elderly (>= 75 years) patients with advanced non-small
cell lung cancer (NSCLC) surviving for at least 6 months when treated with combination of
Avastin (bevacizumab) and weekly docetaxel.


I. To assess the progression free survival and overall survival. II. To determine the
response rate with this regimen. III. To assess the toxicity of this regimen.


Patients receive bevacizumab intravenously (IV) over 30-90 minutes on days 1 and 15 and
docetaxel IV over 60 minutes on days 1, 8, and 15. Courses repeat every 28 days in the
absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for 4 weeks and then up to 6

Inclusion Criteria

Inclusion Criteria

- Patients, who are ≥ 75years, must have histologically or cytologically proven stage
III/IV NSCLC, excluding squamous cell histology (patients with tumors with mixed cell
histologies will be allowed if the squamous cell component is less than 50%) and who
have never received chemotherapy for advanced NSCLC. Patients with squamous cell
histology will be allowed if the primary tumor has been resected. Patients who have
received adjuvant therapy, which did not include docetaxel or avastin, will be
allowed if the adjuvant therapy was completed more than 1 year prior to the detection
of recurrent NSCLC. Stage III patients will be eligible if they are not considered
candidates for concurrent chemotherapy and radiation.

- Patients may have measurable or evaluable disease.

- Life expectancy of greater than 12 weeks.

- ECOG performance status < 2 (Karnofsky > 60%).

- Patients should undergo a brain MRI/CT scan within 4 weeks of study enrollment to
evaluate for brain metastases.

- Patients must have adequate organ and marrow function as defined below:

- leukocytes > 3,000/mcL

- absolute neutrophil count > 1,500/mcL

- platelets > 100,000/mcL

- total bilirubin < 1.5 X institutional upper limit of normal

- AST(SGOT)/ALT(SGPT)< 2.5 X institutional upper limit of normal < 5 X
institutional upper limit of normal if patients has liver metastases

- creatinine < 1.5 X of normal institutional limits

- Cardiac function - MUGA scan or Echocardiogram- Left ventricular function
should be > institutional normal limit

- Ability to understand and the willingness to sign a written informed consent

- Registered with the clinical trials office of the Karmanos Cancer Center/Wayne State

Exclusion Criteria

- Patients with evidence of cavitation in the tumor.

- Patients with mixed histology will be allowed as long as the biopsy has less than 50%
squamous cell histology.

- Patients who have had radiotherapy within 7 days of starting therapy on this study.
Patients should have recovered to grade 1 or less from any adverse effects of the

- Patients with active brain metastases should be excluded. Patients with treated brain
metastases will be allowed on the trial

- Patients cannot start on therapy on this trial < 7 days after completion of treatment
for the brain metastases. Patient can be registered on the trial within 7 days of
completing treatment for brain metastases.

- Brain scan should not have evidence of hemorrhage in the brain

- Patients should have stable or declining dose of steroids.

- Patients with craniotomy will not be able to start therapy for at least 3 months
after craniotomy.

- Patients with resting blood pressure (BP) consistently > 140/90mm of Hg. Patients
whose BP is controlled (< 140 mm of Hg systolic and < 90mm of Hg diastolic) after
adjusting, starting or increasing the medications will be eligible.

- Patients with Urine Protein: Creatinine ratio > 1.0 at screening and/or Patients with
> 1+ protein in the urine. Patients with urine protein > 1+ can be eligible if they
undergo 24 hours urine collection and the urine protein is ≤ 1gin 24 hours.

- Patients with significant hemorrhage (> 30 mL bleeding/episode in previous 3 months)
or hemoptysis that is > 5mL fresh blood in one episode in the previous 3 months.

- Evidence of bleeding diathesis or coagulopathy.

- Current or recent (within 10 days of enrollment) use of aspirin ≥ 325 mg/day or
chronic use of Non-Steroidal Anti-inflammatory Drugs (NSAIDS).

- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days
prior to start of therapy or anticipation of need for major surgical procedure during
the course of the study. Core biopsy or other minor procedure, excluding placement of
a vascular access device within 7 days prior to start of therapy.

- History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess
within 6 months prior to study enrollment.

- Serious non-healing wound, ulcer, or bone fracture.

- Patients may not be receiving any other investigational agents nor have participated
in a trial involving an investigational agent within 30 days of starting therapy on
this trial. Patient should have recovered to grade 1 or less from any adverse effects
from any prior therapy excluding alopecia.

- Patients with history of other active malignancies. If patient has other cancers such
as PSA only (without clinical or radiographic evidence) prostate cancer the patient
can still be considered for this protocol if in the clinical judgment of the treating
physician NSCLC is the most important malignancy and that the other malignancy will
not impact patient's overall survival.

- Patients with history of myocardial infarction or cerebrovascular episode within 1
year of starting therapy on this study.

- Significant vascular disease such as aortic aneurysm, aortic dissection and
symptomatic peripheral vascular disease.

- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, NYHA class II or greater congestive heart failure, unstable angina
pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would
limit compliance with study requirements.

- Known hypersensitivity to any component of Avastin.

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective response

Outcome Description:

Descriptive statistics (point and exact 90% confidence interval estimates) will be generated.

Outcome Time Frame:

Up to 6 months

Safety Issue:


Principal Investigator

Shirish Gadgeel

Investigator Role:

Principal Investigator

Investigator Affiliation:

Barbara Ann Karmanos Cancer Institute


United States: Food and Drug Administration

Study ID:




Start Date:

January 2008

Completion Date:

Related Keywords:

  • Adenocarcinoma of the Lung
  • Bronchoalveolar Cell Lung Cancer
  • Large Cell Lung Cancer
  • Recurrent Non-Small Cell Lung Cancer
  • Stage IIIA Non-Small Cell Lung Cancer
  • Stage IIIB Non-Small Cell Lung Cancer
  • Stage IV Non-Small Cell Lung Cancer
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Adenocarcinoma, Bronchiolo-Alveolar
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



Barbara Ann Karmanos Cancer Institute Detroit, Michigan  48201