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

Phase 2
75 Years
Open (Enrolling)
Lung Cancer

Thank you

Trial Information

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



- To determine the proportion of elderly (≥ 75 years of age) patients with stage III or
IV non-small cell lung cancer surviving for at least 6 months when treated with a
combination of bevacizumab and weekly docetaxel.


- To assess the progression-free and overall survival of patients treated with this

- To determine the response rate in patients treated with this regimen.

- To assess the toxicity of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15 and docetaxel IV on days
1, 8, and 15. Treatment may repeat every 4 weeks in the absence of disease progression or
unacceptable toxicity.

After completion of study treatment, patients are followed for 4 weeks.

Inclusion Criteria


Inclusion criteria:

- Histologically or cytologically confirmed non-small cell lung cancer

- Stage III or IV disease

- Stage III disease allowed, provided the patient is not a candidate for
concurrent chemotherapy and radiotherapy

- Mixed histology allowed, provided the biopsy has less than 50% squamous cell

- Measurable or evaluable disease

Exclusion criteria:

- Squamous cell histology

- Evidence of cavitation in the tumor

- Tumors in close proximity to major blood vessels

- No active, untreated brain metastases

- More than 7 days since prior treatment for brain metastases AND no evidence of
hemorrhage in the lesion

- Stable or declining dose of steroids allowed


Inclusion criteria:

- ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100%

- Life expectancy > 12 weeks

- Leukocytes ≥ 3,000/μL

- Absolute neutrophil count ≥ 1,500/μL

- Platelet count ≥ 100,000/μL

- Total bilirubin ≤ 1.5 times upper limit of normal (ULN)

- AST and ALT ≤ 2.5 times ULN (< 5 times ULN if patients has liver metastases)

- Creatinine ≤ 1.5 times normal

- Left ventricular function ≥ normal by MUGA scan or ECHO

- Urine protein:creatinine ratio ≤ 1.0 AND/OR urine protein ≤ 1+ by dipstick analysis
OR protein ≤ 1 g/24-hour urine collection

- Fertile patients must use effective contraception and women should avoid

Exclusion criteria:

- Resting blood pressure (BP) consistently > 140/90 mm Hg

- Patients whose BP is controlled (≤ 140 mm Hg systolic and ≤ 90 mm Hg diastolic)
after adjusting, starting, or increasing the medications are eligible

- Significant hemorrhage (i.e., > 30 mL bleeding/episode ) or hemoptysis (i.e., > 5 mL
fresh blood in one episode) in the previous 3 months

- Evidence of bleeding diathesis or coagulopathy

- Significant traumatic injury within the past 28 days

- Abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within
the past 6 months

- 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 the other malignancy will not impact patient's overall

- Myocardial infarction or cerebrovascular episode within the past year

- Serious nonhealing wound or ulcer

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

- Uncontrolled concurrent illness that would limit compliance with study requirements
including, but not limited to, the following:

- Ongoing or active infection

- New York Heart Association class II-IV congestive heart failure

- Unstable angina pectoris

- Cardiac arrhythmia

- Psychiatric illness/social situations

- Known hypersensitivity to any component of bevacizumab


- More than 7 days since prior radiotherapy and recovered

- No concurrent full-dose warfarin or its equivalent (i.e., unfractionated and/or low
molecular-weight heparin)

- More than 10 days since prior and no concurrent aspirin ≥ 325 mg/day or chronic use
of nonsteroidal anti-inflammatory drugs

- More than 28 days since prior and no concurrent major surgical procedure or open

- More than 7 days since prior core biopsy or other minor procedure, excluding
placement of a vascular access device

- No other concurrent investigational agents, commercial agents, or therapies

- More than 30 days since prior participation in a trial involving an investigational

- No prior chemotherapy

Type of Study:


Study Design:

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

Outcome Measure:


Outcome Time Frame:

6 months when treated with combination of Avastin and weekly docetaxel

Safety Issue:


Principal Investigator

Shirish M. Gadgeel, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Barbara Ann Karmanos Cancer Institute


United States: Federal Government

Study ID:




Start Date:

January 2008

Completion Date:

February 2013

Related Keywords:

  • Lung Cancer
  • stage IIIA non-small cell lung cancer
  • stage IIIB non-small cell lung cancer
  • stage IV non-small cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



Barbara Ann Karmanos Cancer Institute Detroit, Michigan  48201
Case Comprehensive Cancer Center Cleveland, Ohio  44106-5065
Nevada Cancer Institute Las Vegas, Nevada  89135