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

January 13, 2016 updated by: Nasser Hanna, M.D.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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 Type

Interventional

Enrollment (Actual)

25

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Galesburg, Illinois, United States, 61401
        • Medical & Surgical Specialists, LLC
    • Indiana
      • Bloomington, Indiana, United States, 47403
        • Cancer Care Center of Southern Indiana
      • Evansville, Indiana, United States, 47714
        • Oncology Hematology Associates of SW Indiana
      • Fort Wayne, Indiana, United States, 46815
        • Fort Wayne Oncology & Hematology, Inc
      • Indianapolis, Indiana, United States, 46202
        • Indiana University Cancer Center
      • Indianapolis, Indiana, United States, 46202
        • Quality Cancer Center (MCGOP)
      • Indianapolis, Indiana, United States, 46256
        • Community Regional Cancer Center
      • Lafayette, Indiana, United States, 47905
        • Horizon Oncology Center
      • Lafayette, Indiana, United States, 47904
        • Arnett Cancer Care
      • Muncie, Indiana, United States, 47303
        • Medical Consultants, P.C.
      • South Bend, Indiana, United States, 46601
        • Northern Indiana Cancer Research Consortium
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Methodist Cancer Center
    • Ohio
      • Cincinnati, Ohio, United States, 45247
        • Oncology Partners Network

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Histological proof of non-small cell lung cancer meeting one of the following criteria:

    • stage III b with a pleural effusion
    • stage IV
  • Histology must not be squamous cell.
  • No prior chemotherapy or hormonal therapy.
  • Prior radiation therapy must be completed at least 21 days prior to being registered for protocol therapy.
  • No prior use of an epidermal growth factor receptor (EGFR) inhibitor or antiangiogenic agent.
  • No treatment with any investigational agent within 30 days prior to being registered for protocol therapy.
  • Measurable disease according to RECIST and obtained by imaging within 28 days prior to being registered for protocol therapy.
  • ECOG Performance Status of 2 in the opinion of the treating investigator.
  • Age > 18 years at the time of consent.
  • Females of childbearing potential and males must be willing to use an effective method of contraception (hormonal or barrier method of birth control; abstinence) while on treatment and for a 6 week period thereafter.
  • Females of childbearing potential must have a negative pregnancy test within 7 days prior to being registered for protocol therapy. Subjects are considered not of child bearing potential if they are surgically sterile (they have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are postmenopausal.
  • Females must not be breastfeeding.
  • Able to comply with study and/or follow-up procedures.

Exclusion Criteria:

  • Evidence of bleeding diathesis or coagulopathy.
  • Evidence of central nervous system involvement or brain metastases confirmed by head CT or brain MRI within 28 days prior to being registered for protocol therapy.
  • Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to registration for protocol therapy.
  • Anticipation of need for major surgical procedure during the course of the study.
  • Minor surgical procedures such as fine needle aspirations or core biopsies within 7 days prior to registration for protocol therapy.
  • History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to registration for protocol therapy.
  • Serious, non-healing wound, ulcer, or bone fracture.
  • History of hemoptysis.
  • Clinically significant infections as judged by the treating investigator.
  • Other active malignancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Bevacizumab + erlotinib; if no progressive disease observed, combination or single-agent treatment will continue until unacceptable toxicity or progressive disease.
Drug: Erlotinib
Erlotinib 150 mg qd days 1-21
Drug: Bevacizumab
Bevacizumab 15 mg/kg IV, day 1

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To Establish Rate of Non-progressive Disease at 4 Months in Patients With Advanced NSCLC Who Have Been Designated PS2 by Their Treating Physician
Time Frame: 4 months
4 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall Survival
Time Frame: 12 months
12 months
Time to Progression
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nasser Hanna, M.D.

Collaborators

Genentech, Inc.
Hoosier Cancer Research Network
Walther Cancer Institute

Investigators

  • Study Chair: Nasser Hanna, M.D., Hoosier Oncology Group, LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2006

Primary Completion (Actual)

April 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

August 21, 2006

First Submitted That Met QC Criteria

August 21, 2006

First Posted (Estimate)

August 23, 2006

Study Record Updates

Last Update Posted (Estimate)

February 11, 2016

Last Update Submitted That Met QC Criteria

January 13, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HOG LUN04-77

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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