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A Phase II Trial of Bevacizumab in Combination With First- or Second-Line Therapy in Subjects With Treated Brain Metastases Due to Non-Squamous Non-Small Cell Lung Cancer

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

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Trial Information

A Phase II Trial of Bevacizumab in Combination With First- or Second-Line Therapy in Subjects With Treated Brain Metastases Due to Non-Squamous Non-Small Cell Lung Cancer

Inclusion Criteria:

- Signed informed consent

- Histologically or cytologically confirmed NSCLC except for squamous cell carcinoma

- Treated brain metastases without evidence of progression or hemorrhage after
treatment, as ascertained by clinical examination and brain imaging (MRI or CT)
during the screening period

- Appropriateness for first- or second-line systemic therapy for advanced NSCLC

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

- Age ≥ 18 years

- For women of childbearing potential and sexually active males, use of an accepted and
effective method of contraception (e.g., hormonal or barrier methods, abstinence)
prior to study entry and for the duration of the study

Exclusion Criteria:

- Brain biopsy/neurosurgical procedure performed within 3 months prior to Day 1

- Progressive neurologic symptoms

- Active malignancy other than lung cancer

- Current, recent, or planned participation in an experimental drug study

- Prior treatment with an investigational or marketed agent that acts by
anti-angiogenesis mechanisms

- Gross hemoptysis within 3 months prior to Day 1

- Inadequately controlled hypertension

- Unstable angina or New York Heart Association Grade II or greater congestive heart
failure (CHF)

- Abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6
months prior to Day 1

- Myocardial infarction within 6 months prior to Day 1

- Stroke within 6 months prior to Day 1

- Active symptomatic peripheral vascular disease within 6 months prior to Day 1

- History of significant vascular disease

- Evidence of bleeding diathesis or coagulopathy

- Known hypersensitivity to any components of bevacizumab

- Inadequate organ function

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

- Urine protein/creatinine (UPC) ratio of ≥ 1.0

- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days
prior to Day 1, or anticipation of need for major surgical procedure during the
course of the study

- Pregnancy or lactation

- Known evidence of disseminated intravascular coagulation (DIC)

- Active infection or fever > 38.5°C within 3 days prior to Day 1

- Any other medical condition (including mental illness or substance abuse) deemed by
the clinician to be likely to interfere with a patient's ability to sign informed
consent, cooperate and participate in the study, or interfere with the interpretation
of the results

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Percentage of Participants With Symptomatic National Cancer Institute's Common Terminology Criteria for Adverse Events v3.0 (NCI CTCAE) Grade ≥2 Central Nervous System (CNS) Hemorrhage

Outcome Description:

The percentage of participants with symptomatic NCI CTCAE Grade ≥ 2 CNS hemorrhage, defined as the presence of clinical symptoms determined by the investigator to be directly referable to a Grade ≥ 2 CNS hemorrhage. Grade 1: Asymptomatic, radiographic findings only Grade 2: Medical intervention indicated Grade 3: Ventriculostomy, intracranial pressure (ICP) monitoring, intraventricular thrombolysis, or operative intervention indicated Grade 4: Life-threatening consequences; neurologic deficit or disability Grade 5: Death

Outcome Time Frame:

From the first administration of bevacizumab until 60 days after discontinuation of bevacizumab treatment was reported (up to 2 years)

Safety Issue:


Principal Investigator

David Karlin, M.D.

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

March 2006

Completion Date:

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Brain Neoplasms
  • Brain Cancer
  • Brain Metastases
  • Avastin
  • Lung Cancer
  • Brain Neoplasms
  • Neoplasms
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms
  • Neoplasm Metastasis