CompletedPhase 2NCT00585377

Bevacizumab (Avastin®) + Erlotinib as First-line Therapy for Stage IIIB/IV or Recurrent, Non-squamous Cell Lung Cancer

In an attempt to improve the therapeutic index for initial therapy of metastatic NSCLC, the combination of bevacizumab and erlotinib is being proposed as first-line treatment in place of conventional chemotherapy. This trial is intended to provide pilot data for a future randomized trial of this combination of targeted agents versus conventional chemotherapy for advanced NSCLC.

Checked against the public recordLast updated Sep 24, 2015 · Source: ClinicalTrials.gov

StatusCompleted
PhasePhase 2
U.S. locations1
SponsorUniversity of Utah
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2
Sponsor
University of Utah
Interventions being studied
Drug: Bevacizumab and Erlotinib
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

Inclusion Criteria * Histological or cytological diagnosis of non-squamous, non-small cell lung cancer. Mixed tumors will be categorized by the predominant cell type unless small cell elements are present, in which case the patient is ineligible. * Stage wet IIIB-IV or recurrent disease * No significant hemoptysis (bright red blood\< 1/2 teaspoon or more per episode within 3 months) * Performance status of 0-1 * Prior radiation allowed if \> 15 days. * No prior treatment for metastatic disease. Adjuvant treatment allowed if greater than 6 months has passed. Exclusion Criteria Disease-Specific Exclusions * History of hemoptysis (bright red blood of 1/2 teaspoon or more per episode) within 3 months prior to study enrollment. * Current, ongoing treatment with full-dose warfarin * Current or recent (within 10 days of enrollment) use of aspirin (\>325 mg/day) or chronic use of other NSAIDs. * Performance status =2-4 * Known HIV-related disease General Medical Exclusions Subjects meeting any of the following criteria are ineligible for study entry: * Inability to comply with study and/or follow-up procedures * Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study other than a Genentech-sponsored bevacizumab cancer study Bevacizumab (Avastin®)-Specific Exclusions * Inadequately controlled hypertension (defined as systolic blood pressure \>150 and/or diastolic blood pressure \> 100 mmHg on antihypertensive medications) * Any prior history of hypertensive crisis or hypertensive encephalopathy * New York Heart Association (NYHA) Grade II or greater congestive heart failure (see Appendix E) * 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 * Significant vascular disease (e.g., aortic aneurysm, aortic dissection) * Symptomatic peripheral vascular disease * Evidence of bleeding diathesis or coagulopathy * Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study enrollment or anticipation of need for major surgical procedure during the course of the study * Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to study enrollment * 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 * Proteinuria at screening as demonstrated by either * Urine protein:creatinine (UPC) ratio \> 1.0 at screening OR * Urine dipstick for proteinuria ≥ 2+ (patients discovered to have ≥2+ proteinuria on dipstick urinalysis at baseline should undergo a 24 hour urine collection and must demonstrate ≤ 1g of protein in 24 hours to be eligible). * Known hypersensitivity to any component of bevacizumab * Pregnant (positive pregnancy test) or lactating. Use of effective means of contraception (men and women) in subjects of child-bearing potential

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • University of UtahSalt Lake City, Utah

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Sep 24, 2015. Always confirm current availability with the study team.

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