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Combination Chemotherapy in Treating Patients With Advanced Non-Small Cell Lung Cancer

Sponsor
Eastern Cooperative Oncology Group (Other)
Overall Status
Completed
CT.gov ID
NCT00041314
Collaborator
National Cancer Institute (NCI) (NIH)
79
Locations
58.4
Actual Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

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 Design

Study Type:
Interventional
Primary Purpose:
Treatment
Official Title:
A Phase II Trial Of Carboplatin And Gemcitabine With Exisulind In Patients With Advanced Non-Small Cell Lung Cancer
Actual Study Start Date :
Aug 1, 2002
Actual Primary Completion Date :
Jul 1, 2005
Actual Study Completion Date :
Jun 15, 2007

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 120 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Alabama at Birmingham Comprehensive Cancer Center Birmingham Alabama United States 35294-3300
    2 CCOP - Scottsdale Oncology Program Scottsdale Arizona United States 85259-5404
    3 City of Hope Comprehensive Cancer Center Duarte California United States 91010-3000
    4 Veterans Affairs Medical Center - Palo Alto Palo Alto California United States 94304-1290
    5 Stanford University Medical Center Stanford California United States 94305-5408
    6 CCOP - Colorado Cancer Research Program, Inc. Denver Colorado United States 80224
    7 CCOP - Christiana Care Health Services Wilmington Delaware United States 19899
    8 MBCCOP-Howard University Cancer Center Washington District of Columbia United States 20060
    9 Veterans Affairs Medical Center - Gainesville Gainesville Florida United States 32608-1197
    10 Veterans Affairs Medical Center - Miami Miami Florida United States 33125
    11 H. Lee Moffitt Cancer Center and Research Institute Tampa Florida United States 33612-9497
    12 Veterans Affairs Medical Center - Tampa (Haley) Tampa Florida United States 33612
    13 Emory University Hospital - Atlanta Atlanta Georgia United States 30322
    14 Veterans Affairs Medical Center - Atlanta (Decatur) Decatur Georgia United States 30033
    15 Robert H. Lurie Comprehensive Cancer Center, Northwestern University Chicago Illinois United States 60611-3013
    16 Veterans Affairs Medical Center - Lakeside Chicago Chicago Illinois United States 60611-4494
    17 CCOP - Central Illinois Decatur Illinois United States 62526
    18 CCOP - Evanston Evanston Illinois United States 60201
    19 Evanston Northwestern Health Care Evanston Illinois United States 60201
    20 CCOP - Illinois Oncology Research Association Peoria Illinois United States 61602
    21 CCOP - Carle Cancer Center Urbana Illinois United States 61801
    22 Indiana University Cancer Center Indianapolis Indiana United States 46202-5289
    23 Veterans Affairs Medical Center - Indianapolis (Roudebush) Indianapolis Indiana United States 46202
    24 CCOP - Cedar Rapids Oncology Project Cedar Rapids Iowa United States 52403-1206
    25 CCOP - Iowa Oncology Research Association Des Moines Iowa United States 50309-1016
    26 Holden Comprehensive Cancer Center Iowa City Iowa United States 52242-1009
    27 Burgess Health Center Onawa Iowa United States 51040
    28 CCOP - Wichita Wichita Kansas United States 67214-3882
    29 Veterans Affairs Medical Center - Wichita Wichita Kansas United States 67218
    30 MBCCOP - LSU Health Sciences Center New Orleans Louisiana United States 70112
    31 CCOP - Ochsner New Orleans Louisiana United States 70121
    32 Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Baltimore Maryland United States 21231-2410
    33 New England Medical Center Hospital Boston Massachusetts United States 02111
    34 Beth Israel Deaconess Medical Center Boston Massachusetts United States 02215
    35 CCOP - Ann Arbor Regional Ann Arbor Michigan United States 48106
    36 CCOP - Kalamazoo Kalamazoo Michigan United States 49007-3731
    37 CCOP - Duluth Duluth Minnesota United States 55805
    38 Veterans Affairs Medical Center - Minneapolis Minneapolis Minnesota United States 55417-2399
    39 University of Minnesota Cancer Center Minneapolis Minnesota United States 55455
    40 Mayo Clinic Cancer Center Rochester Minnesota United States 55905
    41 CCOP - Metro-Minnesota Saint Louis Park Minnesota United States 55416
    42 Veterans Affairs Medical Center - Omaha Omaha Nebraska United States 68105
    43 CCOP - Missouri Valley Cancer Consortium Omaha Nebraska United States 68106
    44 CCOP - Southern Nevada Cancer Research Foundation Las Vegas Nevada United States 89106
    45 Norris Cotton Cancer Center Lebanon New Hampshire United States 03756-0002
    46 Veterans Affairs Medical Center - East Orange East Orange New Jersey United States 07019
    47 CCOP - Northern New Jersey Hackensack New Jersey United States 07601
    48 Cancer Institute of New Jersey New Brunswick New Jersey United States 08903
    49 Albert Einstein Clinical Cancer Center Bronx New York United States 10461
    50 MBCCOP-Our Lady of Mercy Cancer Center Bronx New York United States 10466
    51 Veterans Affairs Medical Center - Brooklyn Brooklyn New York United States 11209
    52 Veterans Affairs Medical Center - New York New York New York United States 10010
    53 NYU School of Medicine's Kaplan Comprehensive Cancer Center New York New York United States 10016
    54 CCOP - Merit Care Hospital Fargo North Dakota United States 58122
    55 Ireland Cancer Center Cleveland Ohio United States 44106-5065
    56 Cleveland Clinic Taussig Cancer Center Cleveland Ohio United States 44195
    57 CCOP - Columbus Columbus Ohio United States 43206
    58 CCOP - Toledo Community Hospital Oncology Program Toledo Ohio United States 43623-3456
    59 CCOP - Oklahoma Tulsa Oklahoma United States 74136
    60 CCOP - Geisinger Clinic and Medical Center Danville Pennsylvania United States 17822-2001
    61 Hahnemann University Hospital Philadelphia Pennsylvania United States 19102-1192
    62 University of Pennsylvania Cancer Center Philadelphia Pennsylvania United States 19104
    63 Fox Chase Cancer Center Philadelphia Pennsylvania United States 19111
    64 University of Pittsburgh Cancer Institute Pittsburgh Pennsylvania United States 15213-3489
    65 Veterans Affairs Medical Center - Pittsburgh Pittsburgh Pennsylvania United States 15240-0001
    66 CCOP - MainLine Health Wynnewood Pennsylvania United States 19096
    67 CCOP - Sioux Community Cancer Consortium Sioux Falls South Dakota United States 57104
    68 Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville Campus Nashville Tennessee United States 37212-2637
    69 Vanderbilt-Ingram Cancer Center Nashville Tennessee United States 37232-6307
    70 CCOP - St. Vincent Hospital Cancer Center, Green Bay Green Bay Wisconsin United States 54301
    71 Veterans Affairs Medical Center - Madison Madison Wisconsin United States 53705-2286
    72 University of Wisconsin Comprehensive Cancer Center Madison Wisconsin United States 53792-0001
    73 CCOP - Marshfield Medical Research and Education Foundation Marshfield Wisconsin United States 54449
    74 Medical College of Wisconsin Milwaukee Wisconsin United States 53226-3596
    75 Veterans Affairs Medical Center - Milwaukee (Zablocki) Milwaukee Wisconsin United States 53295
    76 NSW Breast Cancer Institute Westmead New South Wales Australia 2145
    77 MBCCOP - San Juan San Juan Puerto Rico 00927-5800
    78 Veterans Affairs Medical Center - San Juan San Juan Puerto Rico 00927-5800
    79 Pretoria Academic Hospitals Pretoria South Africa 0001

    Sponsors and Collaborators

    • Eastern Cooperative Oncology Group
    • National Cancer Institute (NCI)

    Investigators

    • Study Chair: Gregory A. Masters, MD, NorthShore University HealthSystem

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00041314
    Other Study ID Numbers:
    • CDR0000069467
    • E-E1501
    First Posted:
    Jan 27, 2003
    Last Update Posted:
    Jan 2, 2019
    Last Verified:
    Dec 1, 2018
    Keywords provided by , ,
    recurrent non-small cell lung cancer
    stage IIIB non-small cell lung cancer
    stage IV non-small cell lung cancer
    Additional relevant MeSH terms:
    Lung Neoplasms
    Carcinoma, Non-Small-Cell Lung
    Gemcitabine
    Sulindac sulfone
    Carboplatin

    Study Results

    No Results Posted as of Jan 2, 2019