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A Pilot Study of Bevacizumab Plus Carboplatin and Paclitaxel in Subjects With Advanced, Previously Untreated, Squamous Non-Small Cell Lung Cancer

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

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Trial Information

A Pilot Study of Bevacizumab Plus Carboplatin and Paclitaxel in Subjects With Advanced, Previously Untreated, Squamous Non-Small Cell Lung Cancer

Inclusion Criteria:

- Signed Informed Consent Form(s)

- At least 18 years of age

- Advanced histologically or cytologically confirmed predominant squamous NSCLC

- Subjects with treated brain metastases are eligible if there is no evidence of
progression or hemorrhage after treatment of the brain metastasis/metastases

- Prior treatment for CNS disease as deemed appropriate by the treating physician

- ECOG performance status 0, 1, or 2

- Measurable or evaluable disease

- Use of an accepted and effective method of contraception (hormonal or barrier
methods, abstinence) prior to study entry and for the duration of the study (for
women of childbearing potential and sexually active men)

Exclusion Criteria:

- Prior chemotherapy for metastatic disease

- Adjuvant chemotherapy or prior combined modality therapy (chemotherapy plus
radiotherapy) if < 6 months has elapsed from completion of treatment to Day 1, Cycle

- Extrathoracic metastases as the only sites of disease

- Active malignancy other than lung cancer

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

- Untreated brain metastases

- Presence of intrathoracic lesion(s) with any cavitation

- Gross hemoptysis within 3 months prior to Day 1

- In the opinion of the investigator or local radiologist, evidence of tumor that is
extending into the lumen of a major blood vessel

- Inadequately controlled hypertension

- Unstable angina or NYHA Grade II or greater 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, Cycle 1

- Stroke within 6 months prior to Day 1, Cycle 1

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

- History of significant vascular disease

- Evidence of bleeding diathesis or coagulopathy

- Current, ongoing treatment with full-dose warfarin or its equivalent

- Current or recent use of aspirin (>325 mg/day)

- Known hypersensitivity to any components of bevacizumab

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

- UPC ratio ≥ 1.0

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

- Pregnancy or lactation

- Inadequate organ function

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

Type of Study:


Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Incidence of Grade ≥3 Pulmonary Hemorrhage Adverse Events

Outcome Description:

To estimate the rate of National Cancer Institute Common Terminology for Adverse Events (NCI CTCAE), Version 3.0, Grade ≥3 pulmonary hemorrhage adverse events. Per NCI CTCAE v.3: "Grade 3 = Transfusion, interventional radiology, endoscopic, or operative intervention indicated; radiation therapy (i.e., hemostasis of bleeding site); Grade 4 = Life-threatening consequences; major urgent intervention indicated; Grade 5 = Death."

Outcome Time Frame:

First bevacizumab administration until 60 days after discontinuation of bevacizumab or death

Safety Issue:


Principal Investigator

Leonardo Faoro, M.D.

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

September 2005

Completion Date:

July 2009

Related Keywords:

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