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A Placebo-Controlled, Double-Blind, Multicenter, Randomized, Phase II Study of Bevacizumab in Previously Untreated Extensive-Stage Small Cell Lung Cancer


Phase 2
18 Years
N/A
Not Enrolling
Both
Small Cell Lung Cancer

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Trial Information

A Placebo-Controlled, Double-Blind, Multicenter, Randomized, Phase II Study of Bevacizumab in Previously Untreated Extensive-Stage Small Cell Lung Cancer


Inclusion Criteria:



- Histologically or cytologically documented small cell carcinoma of the bronchus,
classified as extensive-stage disease

- Measurable disease or lesions

- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2

Exclusion Criteria:

- Life expectancy of < 12 weeks

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

- Ongoing or active infection

- Active malignancy other than SCLC or superficial basal/squamous cell carcinoma within
the previous 5 years

- Prior systemic therapy, radiation therapy, or surgery for SCLC

- Inadequate bone marrow function, renal function, or hepatic function

- Serum sodium of < 120 mg/dL

- Inadequately controlled hypertension

- History of hypertensive crisis or hypertensive encephalopathy

- New York Heart Association Class II or greater congestive heart failure

- History of myocardial infarction or unstable angina within 6 months prior to study
enrollment

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

- Known central nervous system disease, except for brain metastases treated with
whole-brain radiotherapy

- Significant vascular disease or recent peripheral arterial thrombosis within 6 months
prior to study enrollment

- History of hemoptysis within 4 weeks prior to study enrollment

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

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

- Core biopsy or other minor surgical procedure, including placement of a vascular
access device, within 7 days prior to Day 1

- History of abdominal fistula or gastrointestinal perforation within 6 months prior to
study enrollment

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

- Known hypersensitivity to any component of bevacizumab

- Pregnant (positive pregnancy test) or lactating

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Progression-free Survival (PFS)

Outcome Description:

Duration of PFS, defined as the time from randomization to disease progression or on-study death, whichever occurred first.

Outcome Time Frame:

Randomization until progression or lost to follow-up (up to 2 years)

Safety Issue:

No

Principal Investigator

David Karlin, M.D.

Investigator Role:

Study Director

Investigator Affiliation:

Genentech

Authority:

United States: Food and Drug Administration

Study ID:

AVF3995g

NCT ID:

NCT00403403

Start Date:

March 2007

Completion Date:

June 2009

Related Keywords:

  • Small Cell Lung Cancer
  • SCLC
  • SALUTE
  • Lung Cancer
  • Avastin
  • Lung Neoplasms
  • Small Cell Lung Carcinoma

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