Clinical trial NCT00553800: Study of Bevacizumab and Erlotinib in Patients With Advanced Non-small Cell Lung Cancer
Official title: Phase II Study of Bevacizumab and Erlotinib in Elderly Patients With Advanced Non-Small Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Carcinoma, Non-Small-Cell Lung
Lead sponsor: Fox Chase Cancer Center
Sponsor class: OTHER
Collaborators: name: Genentech, Inc.
name: OSI Pharmaceuticals
First posted: 2007-11-06
Enrollment: 32
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will evaluate the combination of bevacizumab and erlotinib in elderly patients with advanced non-small cell lung cancer.

Detailed description: There is no definite evidence of a superior therapy for advanced non-small cell lung cancer in elderly patients. With the exception of one known study, single agent erlotinib has not been studied exclusively in the elderly and the combination of erlotinib and bevacizumab has never been studied exclusively in the treatment naive elderly. This is an important population that needs less toxic therapies.

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 \</= 1.5, SGOT \* SGPT \< 5 x ULN
* Able and willing to swallow and absorb oral medication
* Able and willing to sign consent
* Request archival diagnostic tissue for EGFR expression but not required

Exclusion Criteria:

* Proteinuria as demonstrated by UPC ratio \>/= 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

Primary outcomes:
measure: Progression Free Survival (PFS)
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Galloway
country: United States
facility: AtlantiCare Regional Medical Center
state: New Jersey
city: Mount Holly
country: United States
facility: Fox Chase Virtua Health Cancer Program at Memorial
state: New Jersey
city: Paoli
country: United States
facility: Paoli Hospital
state: Pennsylvania
city: Philadelphia
country: United States
facility: Abramson Cnacer Center, University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Pennsylvania Oncology Hematology Associates
state: Pennsylvania
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
city: Sellersville
country: United States
facility: Grand View Hospital
state: Pennsylvania
Study officials:
affiliation: Fox Chase Cancer Center
name: Hossein Borghaei, DO
role: PRINCIPAL_INVESTIGATOR
References:
citation: Phase II study of bevacizumab and erlotinib in treatment-naïve elderly patients (older than age 65) with advanced non-small cell lung cancer (NSCLC). H. Borghaei, R. Mehra, M. M. Millenson, H. Tuttle, K. Ruth, A. J. Magdalinski, D. M. Mintzer, J. W. Lee, G. R. Simon, and C. J. Langer Journal of Clinical Oncology 2010 28:15_suppl, e18019-e18019