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

NCT ID: NCT00367601

Last Updated: 2016-02-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-08-31
• Study Completion Date: 2008-12-31

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.

Conditions

Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

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

Group Type: EXPERIMENTAL

Erlotinib

Intervention Type: DRUG

Erlotinib 150 mg qd days 1-21

Bevacizumab

Intervention Type: DRUG

Bevacizumab 15 mg/kg IV, day 1

Interventions

Erlotinib

Erlotinib 150 mg qd days 1-21

Intervention Type: DRUG

Bevacizumab

Bevacizumab 15 mg/kg IV, day 1

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: collaborator

Walther Cancer Institute

OTHER

Sponsor Role: collaborator

Hoosier Cancer Research Network

OTHER

Sponsor Role: collaborator

Nasser Hanna, M.D.

OTHER

Sponsor Role: lead

Responsible Party

Nasser Hanna, M.D.

Sponsor-Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Nasser Hanna, M.D.

Role: STUDY_CHAIR

Hoosier Oncology Group, LLC

Locations

Medical & Surgical Specialists, LLC

Galesburg, Illinois, United States

Cancer Care Center of Southern Indiana

Bloomington, Indiana, United States

Oncology Hematology Associates of SW Indiana

Evansville, Indiana, United States

Fort Wayne Oncology & Hematology, Inc

Fort Wayne, Indiana, United States

Indiana University Cancer Center

Indianapolis, Indiana, United States

Quality Cancer Center (MCGOP)

Indianapolis, Indiana, United States

Community Regional Cancer Center

Indianapolis, Indiana, United States

Arnett Cancer Care

Lafayette, Indiana, United States

Horizon Oncology Center

Lafayette, Indiana, United States

Medical Consultants, P.C.

Muncie, Indiana, United States

Northern Indiana Cancer Research Consortium

South Bend, Indiana, United States

Methodist Cancer Center

Omaha, Nebraska, United States

Oncology Partners Network

Cincinnati, Ohio, United States

Countries

United States

References

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

Reference Type: RESULT

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.

Reference Type: RESULT

PMID: 23102811 (View on PubMed)

Related Links

http://hoosieroncologygroup.org/

Hoosier Oncology Group Home Page

Other Identifiers

HOG LUN04-77

Identifier Type: -

Identifier Source: org_study_id