Erlotinib + Bevacizumab for PS 2 Chemotherapy Naïve Non-Small Cell Lung Cancer

Lung Cancer Clinical Trial

Official title: A Phase II Study of Erlotinib With Bevacizumab in Chemotherapy Naïve Performance Status (PS) 2 Patients With Advanced Non-Small Cell Lung Cancer

Status Completed

Clinical Trial Summary

The strategy for combining therapeutic agents in cancer treatments has been successful in multiple tumor types, including NSCLC. Erlotinib and bevacizumab target different pathways involved in tumor growth. Nonclinical studies have demonstrated that the combination of bevacizumab and erlotinib results in greater efficacy than either agent alone. Furthermore, because there is little to no overlap in toxicity profile between the two agents, the combination is expected to be well tolerated and may provide even greater benefit for patients who are unable to receive cytotoxic therapy.

Clinical Trial Description

OUTLINE: This is a multi-center study.

• Bevacizumab 15 mg/kg IV on day 1

• Erlotinib 150 mg po qd days 1-21

• Disease Assessment during even numbered cycles

If no progressive disease observed, continue (combination or single agent- see below) until unacceptable toxicity or progressive disease.

If progressive disease observed, treatment will be discontinued.

• Cycles will be repeated every 21 days up to a total of 6 cycles.

• Patients with non-progression after 6 cycles may stay on therapy (single agent erlotinib or the combination) until progressive disease or intolerable toxicity (at the physician discretion).

• Patients who require discontinuation of bevacizumab may receive at investigator's discretion erlotinib alone on study until progression.

• Patients who require discontinuation of erlotinib may receive at investigator's discretion bevacizumab alone until progression.

ECOG Performance Status 2

Hematopoietic:

• Absolute neutrophil count (ANC) > 1,000 mm3

• Platelet count > 100,000 mm3

• Hemoglobin > 8 g/dl

Hepatic:

• Bilirubin < 2 X upper limit of normal.

• Aspartate aminotransferase (AST, SGOT) < 2.5 X upper limit of normal or 5 X if liver involvement.

Renal:

• Urine protein:creatinine ratio 1.0 at screening

Cardiovascular:

• Blood pressure of < 150/100 mmHg.

• No history of unstable angina.

• No history of New York Heart Association (NYHA) Grade II or greater congestive heart failure.

• No history of myocardial infarction within 6 months prior to registration for protocol therapy.

• No history of stroke within 6 months prior to registration for protocol therapy.

• No clinically significant peripheral vascular disease. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms

• NCT number: NCT00367601
• Study type: Interventional
• Source: Hoosier Cancer Research Network
• Status: Completed
• Phase: Phase 2
• Start date: August 2006
• Completion date: December 2008