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

Primary Purpose

Lung Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Erlotinib
Bevacizumab
Sponsored by
Nasser Hanna, M.D.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Medical & Surgical Specialists, LLC
  • Cancer Care Center of Southern Indiana
  • Oncology Hematology Associates of SW Indiana
  • Fort Wayne Oncology & Hematology, Inc
  • Indiana University Cancer Center
  • Quality Cancer Center (MCGOP)
  • Community Regional Cancer Center
  • Arnett Cancer Care
  • Horizon Oncology Center
  • Medical Consultants, P.C.
  • Northern Indiana Cancer Research Consortium
  • Methodist Cancer Center
  • Oncology Partners Network

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Bevacizumab + erlotinib; if no progressive disease observed, combination or single-agent treatment will continue until unacceptable toxicity or progressive disease.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Time to Progression
Overall Survival

Full Information

First Posted
August 21, 2006
Last Updated
January 13, 2016
Sponsor
Nasser Hanna, M.D.
Collaborators
Genentech, Inc., Walther Cancer Institute, Hoosier Cancer Research Network
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1. Study Identification

Unique Protocol Identification Number
NCT00367601
Brief Title
Erlotinib + Bevacizumab for PS 2 Chemotherapy Naïve Non-Small Cell Lung Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
August 2006 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Nasser Hanna, M.D.
Collaborators
Genentech, Inc., Walther Cancer Institute, Hoosier Cancer Research Network

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Bevacizumab + erlotinib; if no progressive disease observed, combination or single-agent treatment will continue until unacceptable toxicity or progressive disease.
Intervention Type
Drug
Intervention Name(s)
Erlotinib
Intervention Description
Erlotinib 150 mg qd days 1-21
Intervention Type
Drug
Intervention Name(s)
Bevacizumab
Intervention Description
Bevacizumab 15 mg/kg IV, day 1
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Time to Progression
Time Frame
12 months
Title
Overall Survival
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nasser Hanna, M.D.
Organizational Affiliation
Hoosier Oncology Group, LLC
Official's Role
Study Chair
Facility Information:
Facility Name
Medical & Surgical Specialists, LLC
City
Galesburg
State/Province
Illinois
ZIP/Postal Code
61401
Country
United States
Facility Name
Cancer Care Center of Southern Indiana
City
Bloomington
State/Province
Indiana
ZIP/Postal Code
47403
Country
United States
Facility Name
Oncology Hematology Associates of SW Indiana
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47714
Country
United States
Facility Name
Fort Wayne Oncology & Hematology, Inc
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46815
Country
United States
Facility Name
Indiana University Cancer Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Quality Cancer Center (MCGOP)
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Community Regional Cancer Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46256
Country
United States
Facility Name
Arnett Cancer Care
City
Lafayette
State/Province
Indiana
ZIP/Postal Code
47904
Country
United States
Facility Name
Horizon Oncology Center
City
Lafayette
State/Province
Indiana
ZIP/Postal Code
47905
Country
United States
Facility Name
Medical Consultants, P.C.
City
Muncie
State/Province
Indiana
ZIP/Postal Code
47303
Country
United States
Facility Name
Northern Indiana Cancer Research Consortium
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46601
Country
United States
Facility Name
Methodist Cancer Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
Oncology Partners Network
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45247
Country
United States

12. IPD Sharing Statement

Citations:
Citation
T. Al Baghdadi, S. Bhatia, W. Harb, J. Maher, J. McClean, S. Nattam, D. Taber, M. Yu, C. Johnson and N. Hanna. Erlotinib and bevacizumab in chemotherapy naïve performance status 2 patients with advanced non-small-cell lung cancer. Accepted (abstract #e19082) at the ASCO annual meeting May 29-June 2, 2009, Orlando, FL
Results Reference
result
PubMed Identifier
23102811
Citation
Riggs H, Jalal SI, Baghdadi TA, Bhatia S, McClean J, Johnson C, Yu M, Taber D, Harb W, Hanna N. Erlotinib and bevacizumab in newly diagnosed performance status 2 or elderly patients with nonsquamous non-small-cell lung cancer, a phase II study of the Hoosier Oncology Group: LUN04-77. Clin Lung Cancer. 2013 May;14(3):224-9. doi: 10.1016/j.cllc.2012.09.004. Epub 2012 Oct 24.
Results Reference
result
Links:
URL
http://hoosieroncologygroup.org/
Description
Hoosier Oncology Group Home Page

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

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