Phase 2
Completed N=32
Study of Bevacizumab and Erlotinib in Patients With Advanced Non-small Cell Lung Cancer
Source: ClinicalTrials.gov NCT00553800 ↗Enrolled (actual)
32
Serious AEs
46.9%
Results posted
Jul 2022
Primary outcomePrimary: Progression Free Survival (PFS) — 6.6 months
Summary
This study will evaluate the combination of bevacizumab and erlotinib in elderly patients with advanced non-small cell lung cancer.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression Free Survival (PFS) |
6.6 | — |
Eligibility Criteria
Inclusion Criteria
- Cytologically or histologic confirmed non-small cell lung cancer, stage IIIB or IV or recurrent after primary surgery or radiotherapy.
- ECOG PS 0-1
- 70 years of age or older
- Must have measurable disease
- ANC > 1500, platelets > 100,000
- Total bilirubin /= 1.0
- Prior treatment with an investigational or marketed inhibitor of the EGFR pathway or anti-angiogenesis agent (includes thalidomide)
- Prior treatment for advanced stage disease, with the exception of surgery or radiation (no systemic)
- History of gross hemoptysis within 1 month of enrollment unless treated with surgery or radiation
- Evidence of bleeding diathesis or coagulopathy or other serious/acute internal bleeding within 6 months of enrollment.
- Current, ongoing treatment with full dose warfarin or equivalent
- Current(within 10 days)use of aspirin (> 325mg/day) or other NSAID with antiplatelet activity
- History of hemorrhagic or thrombotic stoke, TIA, or other CNS bleeding w/in last 6 months. Clinically significant PVD
- Known CNS disease except for treated brain mets.
- Squamous cell histology
- Blood pressure > 150/100 that cannot be ameliorated with standard anti-hypertensives
- History of hypertensive crisis or hypertensive encephalopathy
- NYHA grade II or > CHF
- History of MI within 6 months of enrollment
- Major surgery, open biopsy, significant trauma within 28 days of enrollment
- Pregnancy, lactation
- Abdominal or other fistula, abcess, perforation
Data sourced from ClinicalTrials.gov (NCT00553800). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.