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
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 2
- Sponsor
- University of Utah
- Interventions being studied
- Drug: Bevacizumab and Erlotinib
How this study is categorized
These labels come from structured fields and exact terms in the public record.
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.
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.