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Randomized Double-Blind Placebo Controlled Phase II Trial Evaluating Erlotinib in Non-Smoking Patients With (Bevacizumab-Eligible and Ineligible) Advanced Non-Small Cell Lung Cancer (NSCLC)


Phase 2
18 Years
N/A
Not Enrolling
Both
Recurrent Non-small Cell Lung Cancer, Stage IIIB Non-small Cell Lung Cancer, Stage IV Non-small Cell Lung Cancer

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Trial Information

Randomized Double-Blind Placebo Controlled Phase II Trial Evaluating Erlotinib in Non-Smoking Patients With (Bevacizumab-Eligible and Ineligible) Advanced Non-Small Cell Lung Cancer (NSCLC)


PRIMARY OBJECTIVES:

I. To evaluate the progression-free survival (PFS) of non-smokers with advanced non-small
cell lung cancer randomized to receive treatment with standard care (carboplatin and
paclitaxel with or without bevacizumab) or standard care in combination with erlotinib
hydrochloride.

SECONDARY OBJECTIVES:

I. To evaluate the overall survival of these patients. II. To evaluate the response rate in
these patients. III. To evaluate the relative toxicity of these regimens in these patients.
IV. To determine the frequency of EGFR and Kras mutations in these patients and correlate
mutation status with response rate and PFS.

V. To obtain blood and tissue specimens for further marker-based exploratory analyses
regarding EGFR inhibitors.

VI. To evaluate EGFR positivity by FISH as a predictor of improved PFS in patients treated
with erlotinib hydrochloride.

OUTLINE: This is a multicenter study. Patients are stratified according to gender and
eligibility for bevacizumab therapy (ineligible vs eligible and willing to receive
bevacizumab vs eligible and not willing to receive bevacizumab). Patients are randomized to
1 of 2 treatment arms.

ARM I: Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes (with
or without bevacizumab IV over 30-90 minutes) on day 1. Patients also receive an oral
placebo once daily on days 1-21. Treatment repeats every 21 days for 6 courses in the
absence of disease progression or unacceptable toxicity. After completion of 6 courses,
patients with stable or responding disease may continue to receive placebo (with or without
bevacizumab) as above in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive paclitaxel and carboplatin (with or without bevacizumab) as in arm
I. Patients also receive oral erlotinib hydrochloride once daily on days 1-21. Treatment
repeats every 21 days for 6 courses in the absence of disease progression or unacceptable
toxicity. After completion of 6 courses, patients with stable or responding disease may
continue to receive erlotinib hydrochloride (with or without bevacizumab) as above in the
absence of disease progression or unacceptable toxicity.

Blood and tissue samples are collected for correlative laboratory studies.

After completion of study treatment, patients are followed up periodically for 5 years.


Inclusion Criteria:



- Histologically or cytologically confirmed non-small cell lung cancer, meeting one of
the following criteria:

- Stage IIIB disease with pleural or pericardial effusion or multifocal pleural
involvement

- Stage IV disease

- Recurrent disease after prior curative resection or definitive radiotherapy

- Non-squamous cell histology (for patients planning to receive bevacizumab)

- Has smoked ≤ 100 cigarettes in a lifetime

- Measurable disease as defined by RECIST criteria

- No history of untreated brain metastases

- ECOG performance status 0-1

- ANC ≥ 1,500/mm³

- Platelet count ≥ 100,000/mm³

- Bilirubin ≤ 1.5 mg/dL

- SGOT and SGPT ≤ 3 times upper limit of normal

- Creatinine ≤ 2.0 mg/dL

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No clinically significant ongoing or active infection, symptomatic congestive heart
failure, unstable angina pectoris, symptomatic or uncontrolled cardiac arrhythmia, or
psychiatric illness/social situation that would limit compliance with study
requirements

- No other active, invasive malignancies requiring therapy

- Patients planning to receive bevacizumab must meet the following additional criteria:

- INR ≤ 3 within the past 4 weeks

- Urine protein ≤ 1+ by urine dipstick within the past 4 weeks OR urine
protein:creatinine ratio < 1.0

- No antecedent hemoptysis

- No history of thrombotic or hemorrhagic disorders

- History of hypertension allowed provided it is well controlled (i.e., BP ≤
150/90 mm Hg) and patient has been on a stable regimen of antihypertensive
therapy within the past 4 weeks

- History of myocardial infarction or other evidence of arterial thrombotic
disease (angina) allowed provided there is no evidence of active disease for ≥ 6
months

- No serious non-healing wound, ulcer, or bone fracture within the past 4 weeks

- No abdominal fistula, gastrointestinal perforation,or intra-abdominal abscess
within the past 6 months

- No significant vascular disease (e.g., aortic aneurysm,requires surgical repair,
or recent peripheral arterial thrombosis) within the past 6 months

- No clinically significant cardiovascular disease, including any of the
following:

- Cerebrovascular accident within the past 6 months

- New York Heart Association class II-IV heart failure

- Serious and inadequately controlled cardiac arrhythmia

- Clinically significant peripheral vascular disease (symptomatic with
intermittent claudications or < 6 months since bypass surgery)

- No prior chemotherapy for lung cancer

- More than 3 years since prior chemotherapy for an unrelated condition

- At least 2 weeks since prior radiotherapy and recovered (alopecia and grade 1
neuropathy allowed)

- No prior irradiation to the only site of measurable disease, unless that site has had
subsequent evidence of pathology or radiologic progression

- More than 28 days since prior major surgical procedure (for patients planning to
receive bevacizumab)

- Concurrent stable doses of therapeutic anticoagulation or prophylactic
anticoagulation for venous access devices allowed (for patients planning to receive
bevacizumab)

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Progression-free survival (PFS)

Outcome Time Frame:

From randomization to progression of disease or death, whichever occurs first, up to 5 years

Safety Issue:

No

Principal Investigator

Corey Langer

Investigator Role:

Principal Investigator

Investigator Affiliation:

Eastern Cooperative Oncology Group

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2011-01967

NCT ID:

NCT00976677

Start Date:

January 2010

Completion Date:

Related Keywords:

  • Recurrent Non-Small Cell Lung Cancer
  • Stage IIIB Non-Small Cell Lung Cancer
  • Stage IV Non-Small Cell Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Hurley Medical Center Flint, Michigan  48503
Boulder Community Hospital Boulder, Colorado  80301-9019
Porter Adventist Hospital Denver, Colorado  80210
Rose Medical Center Denver, Colorado  80220
Swedish Medical Center Englewood, Colorado  80110
Sky Ridge Medical Center Lone Tree, Colorado  80124
North Suburban Medical Center Thornton, Colorado  80229
Geisinger Medical Center Danville, Pennsylvania  17822-0001
Abramson Cancer Center of the University of Pennsylvania Philadelphia, Pennsylvania  19104-4283
Ingalls Memorial Hospital Harvey, Illinois  60426
Methodist Medical Center of Illinois Peoria, Illinois  61636
Newark Beth Israel Medical Center Newark, New Jersey  07112
North Colorado Medical Center Greeley, Colorado  80631
McKee Medical Center Loveland, Colorado  80539
Paoli Memorial Hospital Paoli, Pennsylvania  19301-1792
Parkland Memorial Hospital Dallas, Texas  75235
Memorial Hospital Carthage, Illinois  62321
Galesburg Clinic Galesburg, Illinois  61401
Mason District Hospital Havana, Illinois  62644
McDonough District Hospital Macomb, Illinois  61455
BroMenn Regional Medical Center Normal, Illinois  61761
Proctor Hospital Peoria, Illinois  61614
Perry Memorial Hospital Princeton, Illinois  61356
Mercy Medical Center Springfield, Ohio  45504
Bryn Mawr Hospital Bryn Mawr, Pennsylvania  19010
Exempla Lutheran Medical Center Wheat Ridge, Colorado  80033
Eureka Hospital Eureka, Illinois  61530
Graham Hospital Association Canton, Illinois  61520
Saint Joseph Medical Center Joliet, Illinois  60435
Trinity Medical Center Moline, Illinois  61265-1291
Pekin Hospital Pekin, Illinois  61554
Saint Joseph Mercy Hospital Ann Arbor, Michigan  48106
Geisinger Medical Group State College, Pennsylvania  16801
Longmont United Hospital Longmont, Colorado  80501
Zale Lipshy University Hospital Dallas, Texas  75235-7786
Greater Baltimore Medical Center Baltimore, Maryland  21204
Case Western Reserve University Cleveland, Ohio  44106
Presbyterian - Saint Lukes Medical Center - Health One Denver, Colorado  80218
University of Texas Southwestern Medical Center Dallas, Texas  
Lankenau Hospital Wynnewood, Pennsylvania  19096
OSF Saint Francis Medical Center Peoria, Illinois  61637
The Medical Center of Aurora Aurora, Colorado  80012
Penrose-Saint Francis Healthcare Colorado Springs, Colorado  80907
Saint Anthony Central Hospital Denver, Colorado  80204
Exempla Saint Joseph Hospital Denver, Colorado  80218
Colorado Cancer Research Program CCOP Denver, Colorado  80224-2522
Saint Mary's Hospital and Regional Medical Center Grand Junction, Colorado  81502
Saint Mary Corwin Medical Center Pueblo, Colorado  81004
Saint Francis Hospital and Medical Center Hartford, Connecticut  06105
Stoffel, Thomas J MD (UIA Investigator) Moline, Illinois  61265
Garneau, Stewart C MD (UIA Investigator) Moline, Illinois  61265
Sharis, Christine M MD (UIA Investigator) Moline, Illinois  61265
Porubcin, Michael MD (UIA Investigator) Moline, Illinois  61265
Community Cancer Center Foundation Normal, Illinois  61761
Illinois CancerCare-Ottawa Clinic Ottawa, Illinois  61350
Ottawa Regional Hospital and Healthcare Center Ottawa, Illinois  61350
Pekin Cancer Treatment Center Pekin, Illinois  61554
Illinois Oncology Research Association CCOP Peoria, Illinois  61615
Illinois CancerCare-Peoria Peoria, Illinois  61615
Illinois Valley Hospital Peru, Illinois  61354
McFarland Clinic Ames, Iowa  50010
Constantinou, Costas L MD (UIA Investigator) Bettendorf, Iowa  52722
Cedar Rapids Oncology Association Cedar Rapids, Iowa  52403
Mercy Hospital Cedar Rapids, Iowa  52403
Mercy Medical Center-Sioux City Sioux City, Iowa  51104
Saint Luke's Regional Medical Center Sioux City, Iowa  51104
Siouxland Hematology - Oncology Associates Sioux City, Iowa  51101
Michigan Cancer Research Consortium Community Clinical Oncology Program Ann Arbor, Michigan  48106
Oakwood Hospital Dearborn, Michigan  48123
Saint John Hospital and Medical Center Detroit, Michigan  48236
Allegiance Health Jackson, Michigan  49201
Sparrow Hospital Lansing, Michigan  48912
Saint Mary Mercy Hospital Livonia, Michigan  48154
Saint Joseph Mercy Oakland Pontiac, Michigan  48341-2985
Saint Joseph Mercy Port Huron Port Huron, Michigan  48060
Saint Mary's of Michigan Saginaw, Michigan  48601
Saint John Macomb-Oakland Hospital Warren, Michigan  48093
Saint Mary's Medical Center Duluth, Minnesota  55805
Miller-Dwan Hospital Duluth, Minnesota  55805
Fox Chase Cancer Center at Virtua Memorial Hospital of Burlington County Mount Holly, New Jersey  08060
Virtua West Jersey Hospital Voorhees Voorhees, New Jersey  08043
Aultman Health Foundation Canton, Ohio  44710
Geisinger Wyoming Valley Wilkes-Barre, Pennsylvania  18711
Mainline Health CCOP Wynnewood, Pennsylvania  19096
Dean Hematology and Oncology Clinic Madison, Wisconsin  53717
Lake University Ireland Cancer Center Mentor, Ohio  44060
Illinois CancerCare-Bloomington Bloomington%, Illinois  61701
Illinois CancerCare-Canton Canton, Illinois  61520
Illinois CancerCare-Carthage Carthage, Illinois  62321
Illinois CancerCare-Eureka Eureka, Illinois  61530
Illinois CancerCare-Havana Havana, Illinois  62644
Illinois CancerCare-Kewanee Clinic Kewanee, Illinois  61443
Illinois CancerCare-Macomb Macomb, Illinois  61455
Illinois CancerCare-Monmouth Monmouth, Illinois  61462
Illinois CancerCare-Community Cancer Center Normal, Illinois  61761
Illinois CancerCare-Pekin Pekin, Illinois  61603
Illinois CancerCare-Peru Peru, Illinois  61354
Illinois CancerCare-Princeton Princeton, Illinois  61356
Illinois CancerCare-Spring Valley Spring Valley, Illinois  61362
Saint Paul Hospital Dallas, Texas  75235
Spector, David MD (UIA Investigator) Moline, Illinois  61265
Southwest General Health Center Ireland Cancer Center Middleburg Heights, Ohio  44130
UHHS-Chagrin Highlands Medical Center Orange Village, Ohio  44122
UHHS-Westlake Medical Center Westlake, Ohio  44145
Oncology Associates at Mercy Medical Center Cedar Rapids, Iowa  52403
Genesys Regional Medical Center-West Flint Campus Flint, Michigan  48532
Essentia Health Duluth Clinic CCOP Duluth, Minnesota  55805
Geisinger Medical Center-Cancer Center Hazelton Hazleton, Pennsylvania  18201