S0709: Erlotinib With or Without Carboplatin and Paclitaxel in Stage IIIB or Stage IV Non-Small Cell Lung Cancer
NCT ID: NCT00661193
Last Updated: 2020-02-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
59 participants
INTERVENTIONAL
2008-12-31
2016-12-31
Brief Summary
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PURPOSE: This randomized phase II trial is studying how well erlotinib works when given alone or together with carboplatin and paclitaxel in treating patients with stage IIIB or stage IV non-small cell lung cancer.
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Detailed Description
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Primary
* To select a regimen (erlotinib hydrochloride with or without carboplatin and paclitaxel) for further testing against standard treatment, based on median progression-free survival for ≥ 3 months, in patients with stage IIIB or IV non-small cell lung cancer with a Zubrod performance status of 2.
Secondary
* To assess the feasibility of selecting patients for a trial based on central EGFR testing of serum in a cooperative group setting.
* To evaluate the objective tumor response rates (confirmed and unconfirmed, complete and partial response), in a subset of patients with measurable disease.
OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.
* Arm I: Patients receive oral erlotinib hydrochloride once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
* Arm II: Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1 and oral erlotinib hydrochloride once daily on days 2-16. Treatment repeats every 21 days for 4 courses. Beginning in course 5 and for all subsequent courses, patients receive oral erlotinib hydrochloride alone on days 1-21. Courses with erlotinib hydrochloride repeat every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for 1 year and then every 6 months for 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
Patients receive oral erlotinib hydrochloride once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
erlotinib hydrochloride
given orally
Arm II
Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1 and oral erlotinib hydrochloride once daily on days 2-16. Treatment repeats every 21 days for 4 courses. Beginning in course 5 and for all subsequent courses, patients receive oral erlotinib hydrochloride alone on days 1-21. Courses with erlotinib hydrochloride repeat every 21 days in the absence of disease progression or unacceptable toxicity.
carboplatin
given IV
erlotinib hydrochloride
given orally
paclitaxel
given IV
Interventions
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carboplatin
given IV
erlotinib hydrochloride
given orally
paclitaxel
given IV
Eligibility Criteria
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Inclusion Criteria
* Histologically or cytologically confirmed non-small cell lung cancer (NSCLC), including any of the following subtypes:
* Adenocarcinoma
* Large cell carcinoma
* Squamous cell carcinoma
* Unspecified
* Newly diagnosed primary disease OR recurrent disease after prior surgery and/or radiotherapy, meeting 1 of the following staging criteria:
* Selected stage IIIB disease (T4 \[secondary to malignant pleural effusion only\], any N, M0)
* Stage IV disease (any T, any N, M1 \[distant metastases present\])
* Measurable or nonmeasurable disease by CT scan, MRI, x-ray, physical exam, or nuclear scan
* The CT scan from a combined PET/CT scan may only be used to document nonmeasurable disease
* Pleural effusions, ascites, and laboratory parameters are not acceptable as the only evidence of disease
* Shows evidence of EGFR tyrosine kinase inhibitor therapy benefit (i.e., "proteomics positive") prior to study registration
* No untreated brain metastases
* Patients with treated brain metastases are allowed provided metastases have remained controlled for at least two weeks following treatment, AND patient has no residual neurological dysfunction off corticosteroids
* Patients with neurologic abnormalities on physical examination or symptoms must have a negative pretreatment CT or MRI scan of the brain 28 days prior to registration
PATIENT CHARACTERISTICS:
* Zubrod performance status 2
* ANC ≥ 1,500/mm³
* Platelet count ≥ 1,000/mm³
* Serum bilirubin normal
* SGOT or SGPT normal
* Serum creatinine ≤ 2 times upper limit of normal OR creatinine clearance ≥ 50 mL/min
* Willing to provide prior smoking history as requested on the prestudy form
* No gastrointestinal (GI) tract disease resulting in an inability to take enteral medication
* No malabsorption syndrome or requirement for IV alimentation
* No uncontrolled inflammatory GI disease (e.g., Crohn's disease or ulcerative colitis)
* No significant history of cardiac disease, including any of the following:
* Uncontrolled high blood pressure
* Unstable angina
* Congestive heart failure
* Myocardial infarction within the past 6 months
* Cardiac ventricular arrhythmia requiring medication
* No other prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 5 years
* Not pregnant or nursing
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* At least 3 weeks since prior radiotherapy or surgery (thoracic or other major surgery) and recovered
* At least 1 year since prior adjuvant chemotherapy
* No prior systemic hormonal therapy, chemotherapy, or biological therapy for advanced NSCLC
* No prior EGFR inhibitors
* No prior surgical procedures affecting absorption
* No concurrent major surgery
18 Years
120 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
SWOG Cancer Research Network
NETWORK
Responsible Party
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Principal Investigators
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Primo N. Lara, MD
Role: STUDY_CHAIR
University of California, Davis
Locations
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Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Kaiser Permanente - Deer Valley
Antioch, California, United States
Alta Bates Summit Comprehensive Cancer Center
Berkeley, California, United States
Peninsula Medical Center
Burlingame, California, United States
Kaiser Permanente - Fremont
Fremont, California, United States
Kaiser Permanente Medical Center - Hayward
Hayward, California, United States
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States
Contra Costa Regional Medical Center
Martinez, California, United States
Tibotec Therapeutics - Division of Ortho Biotech Products, LP
Marysville, California, United States
El Camino Hospital Cancer Center
Mountain View, California, United States
Sutter Health - Western Division Cancer Research Group
Novato, California, United States
Highland General Hospital
Oakland, California, United States
Alta Bates Summit Medical Center - Summit Campus
Oakland, California, United States
CCOP - Bay Area Tumor Institute
Oakland, California, United States
Kaiser Permanente Medical Center - Oakland
Oakland, California, United States
Epic Care - Oakland
Oakland, California, United States
Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
Orange, California, United States
Kaiser Permanente Medical Center - Redwood City
Redwood City, California, United States
Kaiser Permanente Medical Center - Richmond
Richmond, California, United States
Kaiser Permanente Medical Center - Roseville
Roseville, California, United States
University of California Davis Cancer Center
Sacramento, California, United States
South Sacramento Kaiser-Permanente Medical Center
Sacramento, California, United States
Kaiser Permanente Medical Center - Sacramento
Sacramento, California, United States
Kaiser Permanente Medical Center - San Francisco Geary Campus
San Francisco, California, United States
California Pacific Medical Center - California Campus
San Francisco, California, United States
Kaiser Permanente Medical Center - Santa Teresa
San Jose, California, United States
Doctors Medical Center - San Pablo Campus
San Pablo, California, United States
Kaiser Foundation Hospital - San Rafael
San Rafael, California, United States
Kaiser Permanente Medical Center - Santa Clara Kiely Campus
Santa Clara, California, United States
Kaiser Permanente Medical Center - Santa Rosa
Santa Rosa, California, United States
Kaiser Permanente Medical Center - South San Francisco
South San Francisco, California, United States
Kaiser Permanente Medical Facility - Stockton
Stockton, California, United States
Tahoe Forest Cancer Center
Truckee, California, United States
Kaiser Permanente Medical Center - Vacaville
Vacaville, California, United States
Kaiser Permanente Medical Center - Vallejo
Vallejo, California, United States
Sutter Solano Medical Center
Vallejo, California, United States
Kaiser Permanente Medical Center - Walnut Creek
Walnut Creek, California, United States
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
Hartford, Connecticut, United States
Pearlman Comprehensive Cancer Center at South Georgia Medical Center
Valdosta, Georgia, United States
Kaiser Permanente - Moanalua Medical Center and Clinic
Honolulu, Hawaii, United States
Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
Boise, Idaho, United States
Mountain States Tumor Institute at St. Luke's Regional Medical Center
Boise, Idaho, United States
Saint Luke's Mountain States Tumor Institute - Fruitland
Fruitland, Idaho, United States
Mountain States Tumor Institute - Meridian
Meridian, Idaho, United States
Saint Luke's Mountain States Tumor Institute
Nampa, Idaho, United States
Mountain States Tumor Institute at St. Luke's
Twin Falls, Idaho, United States
Decatur Memorial Hospital Cancer Care Institute
Decatur, Illinois, United States
Regional Cancer Center at Memorial Medical Center
Springfield, Illinois, United States
St. Rose Ambulatory and Surgery Center
Great Bend, Kansas, United States
Hays Medical Center
Hays, Kansas, United States
Hutchinson Hospital Corporation
Hutchinson, Kansas, United States
Kansas City Cancer Centers - West
Kansas City, Kansas, United States
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
Kansas City, Kansas, United States
Kansas City Cancer Centers - Southwest
Overland Park, Kansas, United States
Mount Carmel Regional Cancer Center
Pittsburg, Kansas, United States
Tammy Walker Cancer Center at Salina Regional Health Center
Salina, Kansas, United States
Kansas City Cancer Center - Shawnee Mission
Shawnee Mission, Kansas, United States
St. Francis Comprehensive Cancer Center
Topeka, Kansas, United States
Veterans Affairs Medical Center - Topeka (O'Neil)
Topeka, Kansas, United States
Cancer Center of Kansas, PA - Winfield
Winfield, Kansas, United States
Lahey Clinic Medical Center - Burlington
Burlington, Massachusetts, United States
Saint Joseph Mercy Cancer Center
Ann Arbor, Michigan, United States
CCOP - Michigan Cancer Research Consortium
Ann Arbor, Michigan, United States
Oakwood Cancer Center at Oakwood Hospital and Medical Center
Dearborn, Michigan, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States
Genesys Hurley Cancer Institute
Flint, Michigan, United States
Hurley Medical Center
Flint, Michigan, United States
Van Elslander Cancer Center at St. John Hospital and Medical Center
Grosse Pointe Woods, Michigan, United States
Foote Memorial Hospital
Jackson, Michigan, United States
Sparrow Regional Cancer Center
Lansing, Michigan, United States
St. Mary Mercy Hospital
Livonia, Michigan, United States
St. Joseph Mercy Oakland
Pontiac, Michigan, United States
Mercy Regional Cancer Center at Mercy Hospital
Port Huron, Michigan, United States
Seton Cancer Institute at Saint Mary's - Saginaw
Saginaw, Michigan, United States
St. John Macomb Hospital
Warren, Michigan, United States
Regional Cancer Center at Singing River Hospital
Pascagoula, Mississippi, United States
Truman Medical Center - Hospital Hill
Kansas City, Missouri, United States
Veterans Affairs Medical Center - Kansas City
Kansas City, Missouri, United States
Kansas City Cancer Centers - South
Kansas City, Missouri, United States
Kansas City Cancer Centers - North
Kansas City, Missouri, United States
Kansas City Cancer Centers - East
Lee's Summit, Missouri, United States
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, United States
St. John's Regional Health Center
Springfield, Missouri, United States
Hulston Cancer Center at Cox Medical Center South
Springfield, Missouri, United States
CCOP - Montana Cancer Consortium
Billings, Montana, United States
St. Vincent Healthcare Cancer Care Services
Billings, Montana, United States
Hematology-Oncology Centers of the Northern Rockies - Billings
Billings, Montana, United States
Billings Clinic - Downtown
Billings, Montana, United States
Bozeman Deaconess Cancer Center
Bozeman, Montana, United States
Great Falls Clinic - Main Facility
Great Falls, Montana, United States
Sletten Cancer Institute at Benefis Healthcare
Great Falls, Montana, United States
St. Peter's Hospital
Helena, Montana, United States
Glacier Oncology, PLLC
Kalispell, Montana, United States
Kalispell Regional Medical Center
Kalispell, Montana, United States
Montana Cancer Specialists at Montana Cancer Center
Missoula, Montana, United States
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
Missoula, Montana, United States
Randolph Hospital
Asheboro, North Carolina, United States
Presbyterian Cancer Center at Presbyterian Hospital
Charlotte, North Carolina, United States
Wayne Memorial Hospital, Incorporated
Goldsboro, North Carolina, United States
Moses Cone Regional Cancer Center at Wesley Long Community Hospital
Greensboro, North Carolina, United States
Harrington Cancer Center
Amarillo, Texas, United States
Huntsman Cancer Institute at University of Utah
Salt Lake City, Utah, United States
Danville Regional Medical Center
Danville, Virginia, United States
Ravenel Oncology Center at Memorial Hospital of Martinsville and Henry County
Martinsville, Virginia, United States
Island Hospital Cancer Care Center at Island Hospital
Anacortes, Washington, United States
St. Joseph Cancer Center
Bellingham, Washington, United States
Olympic Hematology and Oncology
Bremerton, Washington, United States
Highline Medical Center Cancer Center
Burien, Washington, United States
Swedish Medical Center - Issaquah Campus
Issaquah, Washington, United States
Columbia Basin Hematology
Kennewick, Washington, United States
Skagit Valley Hospital Cancer Care Center
Mount Vernon, Washington, United States
Harrison Poulsbo Hematology and Onocology
Poulsbo, Washington, United States
Harborview Medical Center
Seattle, Washington, United States
Minor and James Medical, PLLC
Seattle, Washington, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States
Group Health Central Hospital
Seattle, Washington, United States
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
Seattle, Washington, United States
Polyclinic First Hill
Seattle, Washington, United States
University Cancer Center at University of Washington Medical Center
Seattle, Washington, United States
North Puget Oncology at United General Hospital
Sedro-Woolley, Washington, United States
Cancer Care Northwest - Spokane South
Spokane, Washington, United States
Evergreen Hematology and Oncology, PS
Spokane, Washington, United States
Wenatchee Valley Medical Center
Wenatchee, Washington, United States
Rocky Mountain Oncology
Casper, Wyoming, United States
Countries
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Other Identifiers
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S0709
Identifier Type: OTHER
Identifier Source: secondary_id
CDR0000593575
Identifier Type: -
Identifier Source: org_study_id
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