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

NCT00585377 | Completed Phase 2 Results DMC

• 2 other identifiers: HCI24377AVF4236s:
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cancer

Outcome Measures

Primary Outcomes (1)

• Evaluation of Overall Survival

  The length of time from the start of treatment for a disease that patients are still alive.

  2 years

Secondary Outcomes (2)

• Evaluation of Progression-free Survival

  2 years

• Evaluation of Response Rate

  2 years

Study Arms (1)

1

OTHER

Drug: Bevacizumab and Erlotinib

Interventions

Bevacizumab and Erlotinib DRUG

Erlotinib 150 mg/day orally plus bevacizumab 15 mg/kg intravenously every 21 days

Also known as: Bevacizumab: Avastin®, Erlotinib: Tarceva®

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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
• 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

Sponsors & Collaborators

• University of Utah: lead
• Genentech, Inc.: collaborator

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84112, United States

Location

Related Publications (1)

• Akerley W, Boucher K, Rich N, Egbert L, Harker G, Bylund J, Van Duren T, Reddy C. A phase II study of bevacizumab and erlotinib as initial treatment for metastatic non-squamous, non-small cell lung cancer with serum proteomic evaluation. Lung Cancer. 2013 Mar;79(3):307-11. doi: 10.1016/j.lungcan.2012.12.005. Epub 2012 Dec 25.

  PMID: 23273522 DERIVED

MeSH Terms

Conditions

Neoplasms

Interventions

Bevacizumab; Erlotinib Hydrochloride

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Mark Wade
• Organization: Huntsman Cancer Institute

mark.wade@hci.utah.edu

801-213-5746

Study Officials

• Wallace Akerley, MD

  University of Utah

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2007
• First Posted: January 3, 2008
• Study Start: August 1, 2007
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: September 24, 2015
• Results First Posted: September 24, 2015

Record last verified: 2015-08

Locations

US (1)