Erlotinib Hydrochloride With or Without Carboplatin and Paclitaxel in Treating Patients With Stage III-IV Non-small Cell Lung Cancer
NCT ID: NCT00126581
Last Updated: 2019-08-07
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
188 participants
INTERVENTIONAL
2005-08-15
2017-11-28
Brief Summary
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Detailed Description
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I. To determine the distribution of progression-free survival (PFS) in patients with previously untreated advanced adenocarcinoma of the lung who are never or light former smokers treated with either OSI-774 (erlotinib) (erlotinib hydrochloride) alone (arm A) or in combination with carboplatin/paclitaxel (arm B).
SECONDARY OBJECTIVES:
I. To determine the radiographic response rate in patients with previously untreated advanced adenocarcinoma of the lung who are never or light former smokers treated with either OSI-774 (erlotinib) alone (arm A) or in combination with carboplatin/paclitaxel (arm B).
II. To determine the frequency of epidermal growth factor receptor (EGFR) and V-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog (K-ras) mutations and anaplastic lymphoma kinase (ALK) translocations in patients with previously untreated advanced adenocarcinoma of the lung who are never or light former smokers.
III. To determine the response rate and time to progression in patients with and without EGFR mutations treated with either OSI-774 (erlotinib) alone (arm A) or in combination with carboplatin/paclitaxel (arm B).
IV. To determine the response rate and time to progression in patients with and without K-ras mutations treated with either OSI-774 (erlotinib) alone (arm A) or in combination with carboplatin/paclitaxel (arm B).
V. To determine the median and overall survival of patients with previously untreated advanced adenocarcinoma of the lung who are never or light former smokers treated with either OSI-774 (erlotinib) alone (arm A) or in combination with carboplatin/paclitaxel (arm B).
VI. To estimate the response rate, progression-free, and overall survival of patients with echinoderm microtubule associated protein like (EML)4-ALK translocation who received OSI-774 erlotinib alone (arm A) or in combination with carboplatin/paclitaxel (arm B).
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive erlotinib hydrochloride orally (PO) once daily (QD) on days 1-21. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
ARM II: Patients receive erlotinib hydrochloride as in Arm I. Patients also receive paclitaxel intravenously (IV) over 1-3 hours and carboplatin IV over 15-30 minutes on day 1. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. After completion of 6 cycles of treatment, patients may continue to receive erlotinib hydrochloride alone as above.
After completion of study treatment, patients are followed at least every 3 months for 1 year and then every 6 months for up to 2 years.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm I (erlotinib hydrochloride)
Patients receive erlotinib hydrochloride PO QD on days 1-21. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Erlotinib
Given PO
Erlotinib Hydrochloride
Given PO
Arm II (erlotinib hydrochloride, paclitaxel, carboplatin)
Patients receive erlotinib hydrochloride as in arm I. Patients also receive paclitaxel IV over 1-3 hours and carboplatin IV over 15-30 minutes on day 1. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. After completion of 6 cycles of treatment, patients may continue to receive erlotinib hydrochloride alone as above.
Carboplatin
Given IV
Erlotinib
Given PO
Erlotinib Hydrochloride
Given PO
Paclitaxel
Given IV
Interventions
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Carboplatin
Given IV
Erlotinib
Given PO
Erlotinib Hydrochloride
Given PO
Paclitaxel
Given IV
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Pathology block or unstained slides from initial or subsequent diagnosis must be available for sequencing of EGFR, K-ras, Erb-2 and B-raf; patients need to have had at least a core biopsy; patients whose diagnosis was made through a fine needle aspirate will not have sufficient material for mutational analysis and are not eligible
* Select stage IIIB with cytologically documented malignant pleural or pericardial effusion OR stage IV disease
* Patients must be chemotherapy naïve; they may not have received neo-adjuvant or adjuvant chemotherapy
* No prior exposure to OSI-774 (erlotinib) or other treatments targeting the human epidermal growth factor receptor (HER) family axis (e.g., trastuzumab, gefitinib, cetuximab, lapatinib, etc.)
* No uncontrolled central nervous system metastases (i.e., any known central nervous system \[CNS\] lesion which is radiographically unstable, symptomatic and/or requiring corticosteroids); patients must be \>= 3 weeks beyond completing cranial irradiation and off corticosteroid therapy
* \>= 3 weeks since prior radiation therapy
* \>= 3 weeks since prior major surgery
* No treatment with an investigational agent currently or within the last 28 days
* Non-smoker or former light smoker; non-smoker is defined as a person who smoked =\< 100 cigarettes in their lifetime while a former light smoker is a patient who smoked between \> 100 cigarettes AND =\< 10 pack years AND quit \>= 1 year ago; this must be documented on the On-study Form (C-1405)
* Eastern Cooperative Oncology Group (ECOG) 0 or 1
* Non-pregnant and non-nursing
* No dysphagia or active gastrointestinal disease or disorder that alters gastrointestinal motility or absorption; no lack of integrity of the gastrointestinal tract (e.g., a significant surgical resection of the stomach or small bowel); patients unable to swallow intact tablets must be able to swallow tablets dissolved in water
* Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as \>= 20 mm with conventional techniques or as \>= 10 mm with spiral computed tomography (CT) scan; lesions that are considered non-measurable include the following:
* Bone lesions
* Leptomeningeal disease
* Ascites
* Pleural/pericardial effusion
* Lymphangitis cutis/pulmonis
* Abdominal masses that are not confirmed and followed by imaging techniques
* Cystic lesions
* Granulocyte \>= 1,500/mcl
* Platelet count \>= 100,000/mcl
* Hemoglobin \>= 9.0 g/dL
* Total bilirubin =\< upper limit of normal (ULN)
* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\]) =\< 2.5 x ULN
* Creatinine =\< 1.5 mg/dl
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Responsible Party
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Principal Investigators
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Pasi A Janne
Role: PRINCIPAL_INVESTIGATOR
Alliance for Clinical Trials in Oncology
Locations
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East Bay Radiation Oncology Center
Castro Valley, California, United States
Eden Hospital Medical Center
Castro Valley, California, United States
Valley Medical Oncology Consultants-Castro Valley
Castro Valley, California, United States
Bay Area Breast Surgeons Inc
Emeryville, California, United States
Valley Medical Oncology Consultants-Fremont
Fremont, California, United States
Saint Rose Hospital
Hayward, California, United States
Contra Costa Regional Medical Center
Martinez, California, United States
El Camino Hospital
Mountain View, California, United States
Highland General Hospital
Oakland, California, United States
Alta Bates Summit Medical Center - Summit Campus
Oakland, California, United States
Bay Area Tumor Institute
Oakland, California, United States
Hematology and Oncology Associates-Oakland
Oakland, California, United States
Tom K Lee Inc
Oakland, California, United States
Valley Care Health System - Pleasanton
Pleasanton, California, United States
Valley Medical Oncology Consultants
Pleasanton, California, United States
University of California San Diego
San Diego, California, United States
Kaiser Permanente-San Diego Mission
San Diego, California, United States
Veterans Administration-San Diego Medical Center
San Diego, California, United States
UCSF Medical Center-Mount Zion
San Francisco, California, United States
Doctors Medical Center- JC Robinson Regional Cancer Center
San Pablo, California, United States
Middlesex Hospital
Middletown, Connecticut, United States
Beebe Medical Center
Lewes, Delaware, United States
Christiana Care Health System-Christiana Hospital
Newark, Delaware, United States
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States
Holy Cross Hospital
Fort Lauderdale, Florida, United States
Jupiter Medical Center
Jupiter, Florida, United States
Mount Sinai Medical Center
Miami Beach, Florida, United States
Memorial Health University Medical Center
Savannah, Georgia, United States
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States
AMITA Health Adventist Medical Center
La Grange, Illinois, United States
Elkhart General Hospital
Elkhart, Indiana, United States
Community Howard Regional Health
Kokomo, Indiana, United States
IU Health La Porte Hospital
La Porte, Indiana, United States
Saint Joseph Regional Medical Center-Mishawaka
Mishawaka, Indiana, United States
Memorial Hospital of South Bend
South Bend, Indiana, United States
Northern Indiana Cancer Research Consortium
South Bend, Indiana, United States
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa, United States
University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland, United States
MedStar Franklin Square Medical Center/Weinberg Cancer Institute
Baltimore, Maryland, United States
Union Hospital of Cecil County
Elkton, Maryland, United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Mass General/North Shore Cancer Center
Danvers, Massachusetts, United States
Cape Cod Hospital
Hyannis, Massachusetts, United States
Lowell General Hospital
Lowell, Massachusetts, United States
South Shore Hospital
South Weymouth, Massachusetts, United States
Lakeland Medical Center Saint Joseph
Saint Joseph, Michigan, United States
University of Minnesota/Masonic Cancer Center
Minneapolis, Minnesota, United States
Missouri Cancer Associates
Columbia, Missouri, United States
Veterans Administration
Columbia, Missouri, United States
University of Missouri - Ellis Fischel
Columbia, Missouri, United States
Capital Region Medical Center
Jefferson City, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
Missouri Baptist Medical Center
St Louis, Missouri, United States
Center for Cancer Care and Research
St Louis, Missouri, United States
CHI Health Saint Francis
Grand Island, Nebraska, United States
Great Plains Health Callahan Cancer Center
North Platte, Nebraska, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
University Medical Center of Southern Nevada
Las Vegas, Nevada, United States
Saint Joseph Hospital
Nashua, New Hampshire, United States
Cooper Hospital University Medical Center
Camden, New Jersey, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Hematology Oncology Associates of Central New York-East Syracuse
East Syracuse, New York, United States
Northwell Health NCORP
Lake Success, New York, United States
North Shore University Hospital
Manhasset, New York, United States
Long Island Jewish Medical Center
New Hyde Park, New York, United States
Ralph Lauren Center for Cancer Care and Prevention
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Saint Joseph's Hospital Health Center
Syracuse, New York, United States
State University of New York Upstate Medical University
Syracuse, New York, United States
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States
Novant Health Presbyterian Medical Center
Charlotte, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
Wayne Memorial Hospital
Goldsboro, North Carolina, United States
Wayne Radiation Oncology
Goldsboro, North Carolina, United States
Margaret R Pardee Memorial Hospital
Hendersonville, North Carolina, United States
Vidant Oncology-Kinston
Kinston, North Carolina, United States
Wilson Medical Center
Wilson, North Carolina, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Cancer Care Associates
Oklahoma City, Oklahoma, United States
Memorial Hospital of Rhode Island
Pawtucket, Rhode Island, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Miriam Hospital
Providence, Rhode Island, United States
Roper Hospital
Charleston, South Carolina, United States
McLeod Regional Medical Center
Florence, South Carolina, United States
Saint Francis Hospital
Greenville, South Carolina, United States
Greenville Memorial Hospital
Greenville, South Carolina, United States
Greenville Health System Cancer Institute-Eastside
Greenville, South Carolina, United States
Central Vermont Medical Center/National Life Cancer Treatment
Berlin Corners, Vermont, United States
University of Vermont and State Agricultural College
Burlington, Vermont, United States
Rappahannock General Hospital
Kilmarnock, Virginia, United States
Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia, United States
Countries
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Other Identifiers
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NCI-2009-00464
Identifier Type: REGISTRY
Identifier Source: secondary_id
CDR0000437097
Identifier Type: -
Identifier Source: secondary_id
CALGB-30406
Identifier Type: OTHER
Identifier Source: secondary_id
CALGB-30406
Identifier Type: OTHER
Identifier Source: secondary_id
NCI-2009-00464
Identifier Type: -
Identifier Source: org_study_id
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