Erlotinib + Bevacizumab for PS 2 Chemotherapy Naïve Non-Small Cell Lung Cancer
A Phase II Study of Erlotinib With Bevacizumab in Chemotherapy Naïve Performance Status (PS) 2 Patients With Advanced Non-Small Cell Lung Cancer
1 other identifier
interventional
25
1 country
13
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 lung-cancer
Started Aug 2006
Shorter than P25 for phase_2 lung-cancer
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2006
CompletedFirst Submitted
Initial submission to the registry
August 21, 2006
CompletedFirst Posted
Study publicly available on registry
August 23, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2008
CompletedResults Posted
Study results publicly available
February 11, 2016
CompletedFebruary 11, 2016
January 1, 2016
1.7 years
August 21, 2006
January 13, 2016
January 13, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
To Establish Rate of Non-progressive Disease at 4 Months in Patients With Advanced NSCLC Who Have Been Designated PS2 by Their Treating Physician
4 months
Secondary Outcomes (2)
Time to Progression
12 months
Overall Survival
12 months
Study Arms (1)
1
EXPERIMENTALBevacizumab + erlotinib; if no progressive disease observed, combination or single-agent treatment will continue until unacceptable toxicity or progressive disease.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Nasser Hanna, M.D.lead
- Genentech, Inc.collaborator
- Walther Cancer Institutecollaborator
- Hoosier Cancer Research Networkcollaborator
Study Sites (13)
Medical & Surgical Specialists, LLC
Galesburg, Illinois, 61401, United States
Cancer Care Center of Southern Indiana
Bloomington, Indiana, 47403, United States
Oncology Hematology Associates of SW Indiana
Evansville, Indiana, 47714, United States
Fort Wayne Oncology & Hematology, Inc
Fort Wayne, Indiana, 46815, United States
Indiana University Cancer Center
Indianapolis, Indiana, 46202, United States
Quality Cancer Center (MCGOP)
Indianapolis, Indiana, 46202, United States
Community Regional Cancer Center
Indianapolis, Indiana, 46256, United States
Arnett Cancer Care
Lafayette, Indiana, 47904, United States
Horizon Oncology Center
Lafayette, Indiana, 47905, United States
Medical Consultants, P.C.
Muncie, Indiana, 47303, United States
Northern Indiana Cancer Research Consortium
South Bend, Indiana, 46601, United States
Methodist Cancer Center
Omaha, Nebraska, 68114, United States
Oncology Partners Network
Cincinnati, Ohio, 45247, United States
Related Publications (2)
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
RESULTRiggs 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.
PMID: 23102811RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Principal Investigator
- Organization
- Hoosier Cancer Research Network, Inc.
Study Officials
- STUDY CHAIR
Nasser Hanna, M.D.
Hoosier Oncology Group, LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Sponsor-Investigator
Study Record Dates
First Submitted
August 21, 2006
First Posted
August 23, 2006
Study Start
August 1, 2006
Primary Completion
April 1, 2008
Study Completion
December 1, 2008
Last Updated
February 11, 2016
Results First Posted
February 11, 2016
Record last verified: 2016-01