Erlotinib Hydrochloride With or Without Carboplatin and Paclitaxel in Treating Patients With Stage III-IV Non-small Cell Lung Cancer
A Phase II Randomized Study of OSI-774 (Erlotinib) (NSC #718781) With or Without Carboplatin/Paclitaxel in Patients With Previously Untreated Adenocarcinoma of the Lung Who Never Smoked or Were Former Light Smokers
5 other identifiers
interventional
188
1 country
96
Brief Summary
This randomized phase II trial studies how well erlotinib hydrochloride with or without carboplatin and paclitaxel works in treating patients with stage III-IV non-small cell lung cancer. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving erlotinib hydrochloride together with carboplatin and paclitaxel may kill more tumor cells than giving either drug alone.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Aug 2005
Longer than P75 for phase_2
96 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 2, 2005
CompletedFirst Posted
Study publicly available on registry
August 4, 2005
CompletedStudy Start
First participant enrolled
August 15, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2010
CompletedResults Posted
Study results publicly available
April 23, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
November 28, 2017
CompletedAugust 7, 2019
July 1, 2019
4.9 years
August 2, 2005
October 7, 2013
July 24, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
18 Weeks Progression Free Survival (PFS) Rate
The product limit estimator developed by Kaplan Meier will be used to graphically describe progression free survival for patients randomized to each study arm. The 18 week progression-free survival rate was defined as the proportion of patients that were alive progression-free 18 weeks after registration into the study. Disease progression was assessed per modified RECIST criteria, and defined as at least a 20% increase in the sum of the longest diameters of target lesions, in either primary or nodal lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of new lesions. Kaplan-Meier estimate of 18-week progression-free survival was calculated.
At 18 weeks
Secondary Outcomes (2)
Overall Response Rate
Duration of Study (up to 3 years)
Number of Participants With Grade 3, 4 or 5 Adverse Event at Least Possibly Related to Treatment.
Duration of study (up to 3 years)
Other Outcomes (5)
Overall Survival
Time from randomization to death (up to 3 years)
Progression Free Survival (PFS) by Epidermal Growth Factor Receptor (EGFR) Mutation Status
Duration of treatment (up to 3 years)
Overall Response Rate by EGFR Mutation Status
Duration of study (up to 3 years)
- +2 more other outcomes
Study Arms (2)
Arm I (erlotinib hydrochloride)
EXPERIMENTALPatients receive erlotinib hydrochloride PO QD on days 1-21. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Arm II (erlotinib hydrochloride, paclitaxel, carboplatin)
EXPERIMENTALPatients 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.
Interventions
Given IV
Given PO
Given PO
Given IV
Eligibility Criteria
You may qualify if:
- Histologic documentation of primary lung adenocarcinoma including any variant thereof such as pure or mixed bronchioloalveolar carcinoma or adenosquamous cell carcinoma; patients with non-small cell lung cancer (NSCLC) not otherwise specified (NOS) are not eligible
- 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
- +12 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (96)
East Bay Radiation Oncology Center
Castro Valley, California, 94546, United States
Eden Hospital Medical Center
Castro Valley, California, 94546, United States
Valley Medical Oncology Consultants-Castro Valley
Castro Valley, California, 94546, United States
Bay Area Breast Surgeons Inc
Emeryville, California, 94608, United States
Valley Medical Oncology Consultants-Fremont
Fremont, California, 94538, United States
Saint Rose Hospital
Hayward, California, 94545, United States
Contra Costa Regional Medical Center
Martinez, California, 94553-3156, United States
El Camino Hospital
Mountain View, California, 94040, United States
Highland General Hospital
Oakland, California, 94602, United States
Alta Bates Summit Medical Center - Summit Campus
Oakland, California, 94609, United States
Bay Area Tumor Institute
Oakland, California, 94609, United States
Hematology and Oncology Associates-Oakland
Oakland, California, 94609, United States
Tom K Lee Inc
Oakland, California, 94609, United States
Valley Care Health System - Pleasanton
Pleasanton, California, 94588, United States
Valley Medical Oncology Consultants
Pleasanton, California, 94588, United States
University of California San Diego
San Diego, California, 92103, United States
Kaiser Permanente-San Diego Mission
San Diego, California, 92108, United States
Veterans Administration-San Diego Medical Center
San Diego, California, 92161, United States
UCSF Medical Center-Mount Zion
San Francisco, California, 94115, United States
Doctors Medical Center- JC Robinson Regional Cancer Center
San Pablo, California, 94806, United States
Middlesex Hospital
Middletown, Connecticut, 06457, United States
Beebe Medical Center
Lewes, Delaware, 19958, United States
Christiana Care Health System-Christiana Hospital
Newark, Delaware, 19718, United States
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, 20007, United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
Holy Cross Hospital
Fort Lauderdale, Florida, 33308, United States
Jupiter Medical Center
Jupiter, Florida, 33458, United States
Mount Sinai Medical Center
Miami Beach, Florida, 33140, United States
Memorial Health University Medical Center
Savannah, Georgia, 31404, United States
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, 60637, United States
AMITA Health Adventist Medical Center
La Grange, Illinois, 60525, United States
Elkhart General Hospital
Elkhart, Indiana, 46515, United States
Community Howard Regional Health
Kokomo, Indiana, 46904, United States
IU Health La Porte Hospital
La Porte, Indiana, 46350, United States
Saint Joseph Regional Medical Center-Mishawaka
Mishawaka, Indiana, 46545, United States
Memorial Hospital of South Bend
South Bend, Indiana, 46601, United States
Northern Indiana Cancer Research Consortium
South Bend, Indiana, 46628, United States
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242, United States
University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland, 21201, United States
MedStar Franklin Square Medical Center/Weinberg Cancer Institute
Baltimore, Maryland, 21237, United States
Union Hospital of Cecil County
Elkton, Maryland, 21921, United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
Mass General/North Shore Cancer Center
Danvers, Massachusetts, 01923, United States
Cape Cod Hospital
Hyannis, Massachusetts, 02601, United States
Lowell General Hospital
Lowell, Massachusetts, 01854, United States
South Shore Hospital
South Weymouth, Massachusetts, 02190, United States
Lakeland Medical Center Saint Joseph
Saint Joseph, Michigan, 49085, United States
University of Minnesota/Masonic Cancer Center
Minneapolis, Minnesota, 55455, United States
Missouri Cancer Associates
Columbia, Missouri, 65201, United States
Veterans Administration
Columbia, Missouri, 65201, United States
University of Missouri - Ellis Fischel
Columbia, Missouri, 65212, United States
Capital Region Medical Center
Jefferson City, Missouri, 65101, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Missouri Baptist Medical Center
St Louis, Missouri, 63131, United States
Center for Cancer Care and Research
St Louis, Missouri, 63141, United States
CHI Health Saint Francis
Grand Island, Nebraska, 68803, United States
Great Plains Health Callahan Cancer Center
North Platte, Nebraska, 69101, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
University Medical Center of Southern Nevada
Las Vegas, Nevada, 89102, United States
Saint Joseph Hospital
Nashua, New Hampshire, 03060, United States
Cooper Hospital University Medical Center
Camden, New Jersey, 08103, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903, United States
Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
Hematology Oncology Associates of Central New York-East Syracuse
East Syracuse, New York, 13057, United States
Northwell Health NCORP
Lake Success, New York, 11042, United States
North Shore University Hospital
Manhasset, New York, 11030, United States
Long Island Jewish Medical Center
New Hyde Park, New York, 11040, United States
Ralph Lauren Center for Cancer Care and Prevention
New York, New York, 10035, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Saint Joseph's Hospital Health Center
Syracuse, New York, 13203, United States
State University of New York Upstate Medical University
Syracuse, New York, 13210, United States
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599, United States
Novant Health Presbyterian Medical Center
Charlotte, North Carolina, 28204, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Wayne Memorial Hospital
Goldsboro, North Carolina, 27534, United States
Wayne Radiation Oncology
Goldsboro, North Carolina, 27534, United States
Margaret R Pardee Memorial Hospital
Hendersonville, North Carolina, 28791, United States
Vidant Oncology-Kinston
Kinston, North Carolina, 28501, United States
Wilson Medical Center
Wilson, North Carolina, 27893, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
Cancer Care Associates
Oklahoma City, Oklahoma, 73120, United States
Memorial Hospital of Rhode Island
Pawtucket, Rhode Island, 02860, United States
Rhode Island Hospital
Providence, Rhode Island, 02903, United States
Miriam Hospital
Providence, Rhode Island, 02906, United States
Roper Hospital
Charleston, South Carolina, 29401, United States
McLeod Regional Medical Center
Florence, South Carolina, 29506, United States
Saint Francis Hospital
Greenville, South Carolina, 29601, United States
Greenville Memorial Hospital
Greenville, South Carolina, 29605, United States
Greenville Health System Cancer Institute-Eastside
Greenville, South Carolina, 29615, United States
Central Vermont Medical Center/National Life Cancer Treatment
Berlin Corners, Vermont, 05602, United States
University of Vermont and State Agricultural College
Burlington, Vermont, 05405, United States
Rappahannock General Hospital
Kilmarnock, Virginia, 22482, United States
Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia, 23298, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pasi Janne, MD, PhD
- Organization
- Dana-Farber Cancer Institute
Study Officials
- PRINCIPAL INVESTIGATOR
Pasi A Janne
Alliance for Clinical Trials in Oncology
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 2, 2005
First Posted
August 4, 2005
Study Start
August 15, 2005
Primary Completion
June 30, 2010
Study Completion
November 28, 2017
Last Updated
August 7, 2019
Results First Posted
April 23, 2014
Record last verified: 2019-07