- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00041314
Combination Chemotherapy in Treating Patients With Advanced Non-Small Cell Lung Cancer
A Phase II Trial Of Carboplatin And Gemcitabine With Exisulind In Patients With Advanced Non-Small Cell Lung Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of carboplatin, gemcitabine, and exisulind in treating patients who have advanced non-small cell lung cancer.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
OBJECTIVES:
- 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.
Study Type
Phase
- Phase 2
Contacts and Locations
Study Locations
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New South Wales
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Westmead, New South Wales, Australia, 2145
- NSW Breast Cancer Institute
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San Juan, Puerto Rico, 00927-5800
- MBCCOP - San Juan
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San Juan, Puerto Rico, 00927-5800
- Veterans Affairs Medical Center - San Juan
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Pretoria, South Africa, 0001
- Pretoria Academic Hospitals
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Alabama
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Birmingham, Alabama, United States, 35294-3300
- University of Alabama at Birmingham Comprehensive Cancer Center
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Arizona
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Scottsdale, Arizona, United States, 85259-5404
- CCOP - Scottsdale Oncology Program
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California
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Duarte, California, United States, 91010-3000
- City of Hope Comprehensive Cancer Center
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Palo Alto, California, United States, 94304-1290
- Veterans Affairs Medical Center - Palo Alto
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Stanford, California, United States, 94305-5408
- Stanford University Medical Center
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Colorado
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Denver, Colorado, United States, 80224
- CCOP - Colorado Cancer Research Program, Inc.
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Delaware
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Wilmington, Delaware, United States, 19899
- CCOP - Christiana Care Health Services
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District of Columbia
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Washington, District of Columbia, United States, 20060
- MBCCOP-Howard University Cancer Center
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Florida
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Gainesville, Florida, United States, 32608-1197
- Veterans Affairs Medical Center - Gainesville
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Miami, Florida, United States, 33125
- Veterans Affairs Medical Center - Miami
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Tampa, Florida, United States, 33612-9497
- H. Lee Moffitt Cancer Center and Research Institute
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Tampa, Florida, United States, 33612
- Veterans Affairs Medical Center - Tampa (Haley)
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Georgia
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Atlanta, Georgia, United States, 30322
- Emory University Hospital - Atlanta
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Decatur, Georgia, United States, 30033
- Veterans Affairs Medical Center - Atlanta (Decatur)
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Illinois
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Chicago, Illinois, United States, 60611-3013
- Robert H. Lurie Comprehensive Cancer Center, Northwestern University
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Chicago, Illinois, United States, 60611-4494
- Veterans Affairs Medical Center - Lakeside Chicago
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Decatur, Illinois, United States, 62526
- CCOP - Central Illinois
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Evanston, Illinois, United States, 60201
- Evanston Northwestern Health Care
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Evanston, Illinois, United States, 60201
- CCOP - Evanston
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Peoria, Illinois, United States, 61602
- CCOP - Illinois Oncology Research Association
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Urbana, Illinois, United States, 61801
- CCOP - Carle Cancer Center
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Indiana
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Indianapolis, Indiana, United States, 46202-5289
- Indiana University Cancer Center
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Indianapolis, Indiana, United States, 46202
- Veterans Affairs Medical Center - Indianapolis (Roudebush)
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Iowa
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Cedar Rapids, Iowa, United States, 52403-1206
- CCOP - Cedar Rapids Oncology Project
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Des Moines, Iowa, United States, 50309-1016
- CCOP - Iowa Oncology Research Association
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Iowa City, Iowa, United States, 52242-1009
- Holden Comprehensive Cancer Center
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Onawa, Iowa, United States, 51040
- Burgess Health Center
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Kansas
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Wichita, Kansas, United States, 67214-3882
- CCOP - Wichita
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Wichita, Kansas, United States, 67218
- Veterans Affairs Medical Center - Wichita
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Louisiana
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New Orleans, Louisiana, United States, 70121
- CCOP - Ochsner
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New Orleans, Louisiana, United States, 70112
- MBCCOP - LSU Health Sciences Center
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Maryland
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Baltimore, Maryland, United States, 21231-2410
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
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Massachusetts
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Boston, Massachusetts, United States, 02215
- Beth Israel Deaconess Medical Center
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Boston, Massachusetts, United States, 02111
- New England Medical Center Hospital
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Michigan
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Ann Arbor, Michigan, United States, 48106
- CCOP - Ann Arbor Regional
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Kalamazoo, Michigan, United States, 49007-3731
- CCOP - Kalamazoo
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Minnesota
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Duluth, Minnesota, United States, 55805
- CCOP - Duluth
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Minneapolis, Minnesota, United States, 55455
- University of Minnesota Cancer Center
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Minneapolis, Minnesota, United States, 55417-2399
- Veterans Affairs Medical Center - Minneapolis
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Rochester, Minnesota, United States, 55905
- Mayo Clinic Cancer Center
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Saint Louis Park, Minnesota, United States, 55416
- CCOP - Metro-Minnesota
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Nebraska
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Omaha, Nebraska, United States, 68106
- CCOP - Missouri Valley Cancer Consortium
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Omaha, Nebraska, United States, 68105
- Veterans Affairs Medical Center - Omaha
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Nevada
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Las Vegas, Nevada, United States, 89106
- CCOP - Southern Nevada Cancer Research Foundation
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New Hampshire
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Lebanon, New Hampshire, United States, 03756-0002
- Norris Cotton Cancer Center
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New Jersey
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East Orange, New Jersey, United States, 07019
- Veterans Affairs Medical Center - East Orange
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Hackensack, New Jersey, United States, 07601
- CCOP - Northern New Jersey
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New Brunswick, New Jersey, United States, 08903
- Cancer Institute of New Jersey
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New York
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Bronx, New York, United States, 10461
- Albert Einstein Clinical Cancer Center
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Bronx, New York, United States, 10466
- MBCCOP-Our Lady of Mercy Cancer Center
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Brooklyn, New York, United States, 11209
- Veterans Affairs Medical Center - Brooklyn
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New York, New York, United States, 10016
- NYU School of Medicine's Kaplan Comprehensive Cancer Center
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New York, New York, United States, 10010
- Veterans Affairs Medical Center - New York
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North Dakota
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Fargo, North Dakota, United States, 58122
- CCOP - Merit Care Hospital
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Ohio
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Cleveland, Ohio, United States, 44195
- Cleveland Clinic Taussig Cancer Center
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Cleveland, Ohio, United States, 44106-5065
- Ireland Cancer Center
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Columbus, Ohio, United States, 43206
- CCOP - Columbus
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Toledo, Ohio, United States, 43623-3456
- CCOP - Toledo Community Hospital Oncology Program
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Oklahoma
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Tulsa, Oklahoma, United States, 74136
- CCOP - Oklahoma
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Pennsylvania
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Danville, Pennsylvania, United States, 17822-2001
- CCOP - Geisinger Clinic and Medical Center
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Philadelphia, Pennsylvania, United States, 19111
- Fox Chase Cancer Center
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Philadelphia, Pennsylvania, United States, 19104
- University of Pennsylvania Cancer Center
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Philadelphia, Pennsylvania, United States, 19102-1192
- Hahnemann University Hospital
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Pittsburgh, Pennsylvania, United States, 15213-3489
- University of Pittsburgh Cancer Institute
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Pittsburgh, Pennsylvania, United States, 15240-0001
- Veterans Affairs Medical Center - Pittsburgh
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Wynnewood, Pennsylvania, United States, 19096
- CCOP - MainLine Health
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South Dakota
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Sioux Falls, South Dakota, United States, 57104
- CCOP - Sioux Community Cancer Consortium
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Tennessee
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Nashville, Tennessee, United States, 37232-6307
- Vanderbilt-Ingram Cancer Center
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Nashville, Tennessee, United States, 37212-2637
- Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville Campus
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Wisconsin
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Green Bay, Wisconsin, United States, 54301
- CCOP - St. Vincent Hospital Cancer Center, Green Bay
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Madison, Wisconsin, United States, 53792-0001
- University of Wisconsin Comprehensive Cancer Center
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Madison, Wisconsin, United States, 53705-2286
- Veterans Affairs Medical Center - Madison
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Marshfield, Wisconsin, United States, 54449
- CCOP - Marshfield Medical Research and Education Foundation
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Milwaukee, Wisconsin, United States, 53295
- Veterans Affairs Medical Center - Milwaukee (Zablocki)
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Milwaukee, Wisconsin, United States, 53226-3596
- Medical College of Wisconsin
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
DISEASE CHARACTERISTICS:
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Gregory A. Masters, MD, NorthShore University HealthSystem
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Lung Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Protective Agents
- Anticarcinogenic Agents
- Carboplatin
- Sulindac sulfone
- Gemcitabine
Other Study ID Numbers
- CDR0000069467
- E-E1501
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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