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


Phase 2
18 Years
N/A
Not Enrolling
Both
Lung Cancer

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

To establish rate of non-progressive disease at 4 months in patients with advanced NSCLC who have been designated PS2 by their treating physician

Outcome Time Frame:

4 months

Safety Issue:

No

Principal Investigator

Nasser Hanna, M.D.

Investigator Role:

Study Chair

Investigator Affiliation:

Hoosier Oncology Group, LLC

Authority:

United States: Institutional Review Board

Study ID:

HOG LUN04-77

NCT ID:

NCT00367601

Start Date:

August 2006

Completion Date:

December 2008

Related Keywords:

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

Name

Location

Indiana University Cancer CenterIndianapolis, Indiana  46202-5265
Methodist Cancer CenterOmaha, Nebraska  68114
Oncology Partners NetworkCincinnati, Ohio  45238
Arnett Cancer CareLafayette, Indiana  47904
Northern Indiana Cancer Research ConsortiumSouth Bend, Indiana  
Medical & Surgical Specialists, LLCGalesburg, Illinois  61401
Cancer Care Center Of Southern IndianaBloomington, Indiana  47403
Horizon Oncology CenterLafayette, Indiana  47905
Oncology Hematology Associates of SW IndianaEvansville, Indiana  47714
Community Regional Cancer CenterIndianapolis, Indiana  46256
Quality Cancer Center (MCGOP)Indianapolis, Indiana  46202
Medical Consultants, P.C.Muncie, Indiana  47303
Fort Wayne Oncology & Hematology, IncFort Wayne, Indiana  46815