Trastuzumab Plus Chemotherapy in Treating Patients With Advanced Non-small Cell Lung Cancer
NCT ID: NCT00003881
Last Updated: 2013-06-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
INTERVENTIONAL
1999-05-31
2004-07-31
Brief Summary
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PURPOSE: Phase II trial to study the effectiveness of the monoclonal antibody trastuzumab plus carboplatin and paclitaxel in treating patients who have advanced non-small cell lung cancer.
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Detailed Description
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OUTLINE: Patients receive paclitaxel IV over 3 hours immediately followed by carboplatin IV over 30 minutes immediately followed by monoclonal antibody HER2 IV over 30-90 minutes on day 1. Patients also receive monoclonal antibody HER2 on days 8 and 15. Treatment is repeated every 3 weeks for 6 courses. After 6 courses of treatment, patients may receive monoclonal antibody HER2 weekly for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years, every 6 months for 3 years and once a year thereafter until disease progression or death.
PROJECTED ACCRUAL: A total of 22-44 patients will be accrued for this study.
Conditions
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Study Design
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TREATMENT
Interventions
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trastuzumab
carboplatin
paclitaxel
Eligibility Criteria
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Inclusion Criteria
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL Transaminases no greater than 5 times upper limit of normal Renal: Creatinine no greater than 2 mg/dL Cardiovascular: No uncontrolled angina pectoris and arrhythmias No myocardial infarction within past 3 months No uncompensated congestive heart failure Ejection fraction at least 45% Other: No active infections Not pregnant or nursing Fertile patients must use effective contraception HIV negative No other active malignancies No evidence of peripheral sensory neuropathy of at least grade 2
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Eastern Cooperative Oncology Group
NETWORK
Principal Investigators
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Corey J. Langer, MD
Role: STUDY_CHAIR
Fox Chase Cancer Center
Locations
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CCOP - Scottsdale Oncology Program
Scottsdale, Arizona, United States
Beckman Research Institute, City of Hope
Los Angeles, California, United States
Veterans Affairs Medical Center - Palo Alto
Palo Alto, California, United States
Stanford University Medical Center
Stanford, California, United States
CCOP - Colorado Cancer Research Program, Inc.
Denver, Colorado, United States
CCOP - Christiana Care Health Services
Wilmington, Delaware, United States
Walter Reed Army Medical Center
Washington D.C., District of Columbia, United States
Veterans Affairs Medical Center - Gainsville
Gainesville, Florida, United States
Sylvester Cancer Center, University of Miami
Miami, Florida, United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States
Veterans Affairs Medical Center - Tampa (Haley)
Tampa, Florida, United States
Emory University Hospital - Atlanta
Atlanta, Georgia, United States
Veterans Affairs Medical Center - Atlanta (Decatur)
Decatur, Georgia, United States
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois, United States
Veterans Affairs Medical Center - Chicago (Lakeside)
Chicago, Illinois, United States
CCOP - Central Illinois
Decatur, Illinois, United States
CCOP - Evanston
Evanston, Illinois, United States
CCOP - Illinois Oncology Research Association
Peoria, Illinois, United States
CCOP - Carle Cancer Center
Urbana, Illinois, United States
Indiana University Cancer Center
Indianapolis, Indiana, United States
Veterans Affairs Medical Center - Indianapolis (Roudebush)
Indianapolis, Indiana, United States
CCOP - Cedar Rapids Oncology Project
Cedar Rapids, Iowa, United States
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, United States
CCOP - Wichita
Wichita, Kansas, United States
MBCCOP - LSU Medical Center
New Orleans, Louisiana, United States
CCOP - Ochsner
New Orleans, Louisiana, United States
Johns Hopkins Oncology Center
Baltimore, Maryland, United States
New England Medical Center Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
CCOP - Ann Arbor Regional
Ann Arbor, Michigan, United States
CCOP - Kalamazoo
Kalamazoo, Michigan, United States
CCOP - Duluth
Duluth, Minnesota, United States
Veterans Affairs Medical Center - Minneapolis
Minneapolis, Minnesota, United States
Mayo Clinic Cancer Center
Rochester, Minnesota, United States
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, United States
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, United States
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, United States
Veterans Affairs Medical Center - East Orange
East Orange, New Jersey, United States
CCOP - Northern New Jersey
Hackensack, New Jersey, United States
Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
Veterans Affairs Medical Center - Albany
Albany, New York, United States
Veterans Affairs Medical Center - Brooklyn
Brooklyn, New York, United States
Veterans Affairs Medical Center - New York
New York, New York, United States
Kaplan Cancer Center
New York, New York, United States
University of Rochester Cancer Center
Rochester, New York, United States
Albert Einstein Comprehensive Cancer Center
The Bronx, New York, United States
CCOP - Merit Care Hospital
Fargo, North Dakota, United States
Ireland Cancer Center
Cleveland, Ohio, United States
Veterans Affairs Medical Center - Cleveland
Cleveland, Ohio, United States
CCOP - Columbus
Columbus, Ohio, United States
CCOP - Toledo Community Hospital Oncology Program
Toledo, Ohio, United States
CCOP - St. Francis Hospital/Natalie Warren Bryant Cancer Center
Tulsa, Oklahoma, United States
CCOP - Geisinger Clinical and Medical Center
Danville, Pennsylvania, United States
Allegheny University Hospitals- Hahnemann
Philadelphia, Pennsylvania, United States
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, United States
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States
Veterans Affairs Medical Center - Pittsburgh
Pittsburgh, Pennsylvania, United States
CCOP - MainLine Health
Wynnewood, Pennsylvania, United States
CCOP - Sioux Community Cancer Consortium
Sioux Falls, South Dakota, United States
Veterans Affairs Medical Center - Nashville
Nashville, Tennessee, United States
Vanderbilt Cancer Center
Nashville, Tennessee, United States
Veterans Affairs Medical Center - Madison
Madison, Wisconsin, United States
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States
CCOP - Marshfield Medical Research and Education Foundation
Marshfield, Wisconsin, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Veterans Affairs Medical Center - Milwaukee (Zablocki)
Milwaukee, Wisconsin, United States
MBCCOP - San Juan
San Juan, , Puerto Rico
Veterans Affairs Medical Center - San Juan
San Juan, , Puerto Rico
Pretoria Academic Hospital
Pretoria, , South Africa
Countries
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References
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Langer CJ, Stephenson P, Thor A, Vangel M, Johnson DH; Eastern Cooperative Oncology Group Study 2598. Trastuzumab in the treatment of advanced non-small-cell lung cancer: is there a role? Focus on Eastern Cooperative Oncology Group study 2598. J Clin Oncol. 2004 Apr 1;22(7):1180-7. doi: 10.1200/JCO.2004.04.105. Epub 2004 Feb 23.
Huang C, Stephenson P, Langer CJ, et al.: Trastuzumab in combination with paclitaxel/carboplatin in advanced non-small cell lung cancer: final report of ECOG 2598. [Abstract] Lung Cancer 41 (Suppl 2): A-P628, S251, 2003.
Schiller J, Langer CJ, Thor A, et al.: Trastuzumab in combination with paclitaxel/carboplatin advanced non-small cell lung cancer: final report of ECOG 2598. [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-2606, 2003.
Langer CJ, Adak S, Thor A, et al.: Phase II Eastern Cooperative Oncology Group (ECOG) pilot study of paclitaxel (P), carboplatin (C), and trastuzumab (T) in HER-2/neu (+) advanced non-small cell lung cancer (NSCLC): early analysis of E2598. [Abstract] Proceedings of the American Society of Clinical Oncology 20: A-1257, 2001.
Other Identifiers
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ECOG-2598
Identifier Type: -
Identifier Source: secondary_id
CDR0000067048
Identifier Type: -
Identifier Source: org_study_id
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