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

Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00367601
• Other study ID #: HOG LUN04-77
• Status: Completed
• Phase: Phase 2
• First received: August 21, 2006
• Last updated: January 13, 2016
• Start date: August 2006
• Est. completion date: December 2008

Study information

• Verified date: January 2016
• Source: Hoosier Cancer Research Network
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: December 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms

Intervention

Drug:
• Erlotinib
Erlotinib 150 mg qd days 1-21
• Bevacizumab
Bevacizumab 15 mg/kg IV, day 1

Locations

Country	Name	City	State
United States	Cancer Care Center of Southern Indiana	Bloomington	Indiana
United States	Oncology Partners Network	Cincinnati	Ohio
United States	Oncology Hematology Associates of SW Indiana	Evansville	Indiana
United States	Fort Wayne Oncology & Hematology, Inc	Fort Wayne	Indiana
United States	Medical & Surgical Specialists, LLC	Galesburg	Illinois
United States	Community Regional Cancer Center	Indianapolis	Indiana
United States	Indiana University Cancer Center	Indianapolis	Indiana
United States	Quality Cancer Center (MCGOP)	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	Methodist Cancer Center	Omaha	Nebraska
United States	Northern Indiana Cancer Research Consortium	South Bend	Indiana

Sponsors (4)

Lead Sponsor	Collaborator
Nasser Hanna, M.D.	Genentech, Inc., Hoosier Cancer Research Network, Walther Cancer Institute

Country where clinical trial is conducted

United States, 

References & Publications (2)

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 Hoos — View 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 #e190

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Time to Progression		12 months	No
Secondary	Overall Survival		12 months	No

External Links

•   Hoosier Oncology Group Home Page