Combination Chemotherapy in Treating Patients With Advanced Non-Small Cell Lung Cancer
NCT ID: NCT00041314
Last Updated: 2023-06-15
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
2002-10-04
2007-06-15
Brief Summary
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PURPOSE: Phase II trial to study the effectiveness of carboplatin, gemcitabine, and exisulind in treating patients who have advanced non-small cell lung cancer.
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Detailed Description
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* Determine the 18-month survival rate in patients with advanced non-small cell lung cancer treated with carboplatin, gemcitabine, and exisulind.
* Determine the feasibility and toxicity of this regimen in these patients.
* Determine the response rate, progression-free survival, and overall median survival of patients treated with this regimen.
OUTLINE: Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and carboplatin IV over 30 minutes on day 1. Chemotherapy repeats every 21 days for up to 6 courses. Patients also receive oral exisulind twice daily beginning on day 1 of course 1 and continuing until disease progression or unacceptable toxicity occurs.
Patients are followed every 3 months for 2 years and then every 6 months for 2 years.
PROJECTED ACCRUAL: A total of 55 patients will be accrued for this study within 6 months.
Conditions
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Study Design
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TREATMENT
Interventions
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carboplatin
exisulind
gemcitabine hydrochloride
Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed non-small cell lung cancer (NSCLC)
* Unresectable stage IIIB (e.g., pleural effusion) not suitable for combined modality therapy OR
* Stage IV
* Prior brain metastases are allowed provided the following are true:
* Patient completed radiotherapy and/or surgery at least 3 weeks prior to study
* Objective evidence of resolution or significant improvement of brain lesions exists on follow-up CT scan or MRI
* Patient is neurologically improved or stable
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* ECOG 0-1
Life expectancy:
* Not specified
Hematopoietic:
* Absolute granulocyte count at least 1,500/mm\^3
* WBC at least 3,000/mm\^3
* Hemoglobin at least 9 g/L
* Platelet count at least 100,000/mm\^3
Hepatic:
* Bilirubin no greater than 1.25 mg/dL
* SGOT no greater than 1.5 times upper limit of normal
Renal:
* Creatinine no greater than 2.0 mg/dL OR
* Creatinine clearance at least 50 mL/min
Cardiovascular:
* No prior uncontrolled cardiovascular disease
* No hospitalization for acute myocardial infarction, arrhythmia, or congestive heart failure within the past 3 months
Other:
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective nonhormonal contraception
* No serious active infection
* No dementia or active psychoses
* No other prior malignancy except nonmetastatic nonmelanoma skin cancer, carcinoma in situ of the cervix, or cancer curatively treated with surgery or small-field radiotherapy within the past 5 years
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* No prior chemotherapy
Endocrine therapy:
* Not specified
Radiotherapy:
* See Disease Characteristics
* At least 3 weeks since prior radiotherapy
Surgery:
* See Disease Characteristics
Other:
* At least 1 month since prior investigational agents
* More than 7 days since prior aspirin, sulindac, cyclo-oxygenase-2 (COX-2) inhibitors, or nonsteroidal anti-inflammatory drugs (except ibuprofen or naproxen)
* No concurrent sulindac or COX-2 inhibitors
18 Years
120 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Eastern Cooperative Oncology Group
NETWORK
Principal Investigators
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Gregory A. Masters, MD
Role: STUDY_CHAIR
Endeavor Health
Locations
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University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, United States
CCOP - Scottsdale Oncology Program
Scottsdale, Arizona, United States
City of Hope Comprehensive Cancer Center
Duarte, 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
MBCCOP-Howard University Cancer Center
Washington D.C., District of Columbia, United States
Veterans Affairs Medical Center - Gainesville
Gainesville, Florida, United States
Veterans Affairs Medical Center - 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 - Lakeside Chicago
Chicago, Illinois, United States
CCOP - Central Illinois
Decatur, Illinois, United States
CCOP - Evanston
Evanston, Illinois, United States
Evanston Northwestern Health Care
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
Holden Comprehensive Cancer Center
Iowa City, Iowa, United States
Burgess Health Center
Onawa, Iowa, United States
CCOP - Wichita
Wichita, Kansas, United States
Veterans Affairs Medical Center - Wichita
Wichita, Kansas, United States
MBCCOP - LSU Health Sciences Center
New Orleans, Louisiana, United States
CCOP - Ochsner
New Orleans, Louisiana, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
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
University of Minnesota Cancer Center
Minneapolis, Minnesota, United States
Mayo Clinic Cancer Center
Rochester, Minnesota, United States
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, United States
Veterans Affairs Medical Center - Omaha
Omaha, Nebraska, United States
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, United States
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, United States
Norris Cotton Cancer Center
Lebanon, New Hampshire, 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 - Brooklyn
Brooklyn, New York, United States
Veterans Affairs Medical Center - New York
New York, New York, United States
NYU School of Medicine's Kaplan Comprehensive Cancer Center
New York, New York, United States
Albert Einstein Clinical Cancer Center
The Bronx, New York, United States
MBCCOP-Our Lady of Mercy Cancer Center
The Bronx, New York, United States
CCOP - Merit Care Hospital
Fargo, North Dakota, United States
Ireland Cancer Center
Cleveland, Ohio, United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States
CCOP - Columbus
Columbus, Ohio, United States
CCOP - Toledo Community Hospital Oncology Program
Toledo, Ohio, United States
CCOP - Oklahoma
Tulsa, Oklahoma, United States
CCOP - Geisinger Clinic and Medical Center
Danville, Pennsylvania, United States
Hahnemann University Hospital
Philadelphia, Pennsylvania, United States
University of Pennsylvania Cancer Center
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 - Tennessee Valley Healthcare System - Nashville Campus
Nashville, Tennessee, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
CCOP - St. Vincent Hospital Cancer Center, Green Bay
Green Bay, Wisconsin, 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
NSW Breast Cancer Institute
Westmead, New South Wales, Australia
MBCCOP - San Juan
San Juan, , Puerto Rico
Veterans Affairs Medical Center - San Juan
San Juan, , Puerto Rico
Pretoria Academic Hospitals
Pretoria, , South Africa
Countries
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References
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Masters GA, Li S, Dowlati A, Madajewicz S, Langer C, Schiller J, Johnson D. A phase II trial of carboplatin and gemcitabine with exisulind (IND #65,056) in patients with advanced non-small cell lung cancer: an Eastern Cooperative Oncology Group study (E1501). J Thorac Oncol. 2006 Sep;1(7):673-8.
Other Identifiers
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E-E1501
Identifier Type: -
Identifier Source: secondary_id
CDR0000069467
Identifier Type: -
Identifier Source: org_study_id
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