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A Phase II Trial Of Carboplatin And Gemcitabine With Exisulind In Patients With Advanced Non-Small Cell Lung Cancer


Phase 2
18 Years
N/A
Not Enrolling
Both
Lung Cancer

Thank you

Trial Information

A Phase II Trial Of Carboplatin And Gemcitabine With Exisulind In Patients With Advanced Non-Small Cell Lung Cancer


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.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Gregory A. Masters, MD

Investigator Role:

Study Chair

Investigator Affiliation:

NorthShore University HealthSystem Research Institute

Authority:

United States: Federal Government

Study ID:

CDR0000069467

NCT ID:

NCT00041314

Start Date:

August 2002

Completion Date:

Related Keywords:

  • Lung Cancer
  • recurrent non-small cell lung cancer
  • stage IIIB non-small cell lung cancer
  • stage IV non-small cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Mayo Clinic Cancer CenterRochester, Minnesota  55905
Stanford University Medical CenterStanford, California  94305-5408
H. Lee Moffitt Cancer Center and Research InstituteTampa, Florida  33612
Emory University Hospital - AtlantaAtlanta, Georgia  30322
Indiana University Cancer CenterIndianapolis, Indiana  46202-5265
CCOP - Ann Arbor RegionalAnn Arbor, Michigan  48106
University of Minnesota Cancer CenterMinneapolis, Minnesota  55455
Ireland Cancer CenterCleveland, Ohio  44106-5065
University of Pennsylvania Cancer CenterPhiladelphia, Pennsylvania  19104
Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
Robert H. Lurie Comprehensive Cancer Center, Northwestern UniversityChicago, Illinois  60611
CCOP - WichitaWichita, Kansas  67214-3882
CCOP - Missouri Valley Cancer ConsortiumOmaha, Nebraska  68131
CCOP - Southern Nevada Cancer Research FoundationLas Vegas, Nevada  89106
CCOP - Christiana Care Health ServicesWilmington, Delaware  19899
Norris Cotton Cancer CenterLebanon, New Hampshire  03756
CCOP - Colorado Cancer Research Program, Inc.Denver, Colorado  80209-5031
Veterans Affairs Medical Center - Atlanta (Decatur)Decatur, Georgia  30033
CCOP - Illinois Oncology Research AssociationPeoria, Illinois  61602
CCOP - Carle Cancer CenterUrbana, Illinois  61801
Veterans Affairs Medical Center - Indianapolis (Roudebush)Indianapolis, Indiana  46202
CCOP - Iowa Oncology Research AssociationDes Moines, Iowa  50309-1016
Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215
New England Medical Center HospitalBoston, Massachusetts  02111
CCOP - KalamazooKalamazoo, Michigan  49007-3731
CCOP - Metro-MinnesotaSaint Louis Park, Minnesota  55416
Veterans Affairs Medical Center - East OrangeEast Orange, New Jersey  07018-1095
CCOP - Northern New JerseyHackensack, New Jersey  07601
Hahnemann University HospitalPhiladelphia, Pennsylvania  19102-1192
University of Pittsburgh Cancer InstitutePittsburgh, Pennsylvania  15213
CCOP - DuluthDuluth, Minnesota  55805
Vanderbilt-Ingram Cancer CenterNashville, Tennessee  37232-6838
CCOP - Scottsdale Oncology ProgramScottsdale, Arizona  85259-5404
CCOP - Cedar Rapids Oncology ProjectCedar Rapids, Iowa  52403-1206
CCOP - OchsnerNew Orleans, Louisiana  70121
CCOP - Merit Care HospitalFargo, North Dakota  58122
CCOP - Toledo Community Hospital Oncology ProgramToledo, Ohio  43623-3456
CCOP - Sioux Community Cancer ConsortiumSioux Falls, South Dakota  57105-1080
University of Alabama at Birmingham Comprehensive Cancer CenterBirmingham, Alabama  35294-3300
NYU School of Medicine's Kaplan Comprehensive Cancer CenterNew York, New York  10016
Medical College of WisconsinMilwaukee, Wisconsin  53226
CCOP - Central IllinoisSpringfield, Illinois  62526
CCOP - ColumbusColumbus, Ohio  43206
CCOP - MainLine HealthWynnewood, Pennsylvania  19096
Veterans Affairs Medical Center - MadisonMadison, Wisconsin  53705
University of Wisconsin Comprehensive Cancer CenterMadison, Wisconsin  53792
Veterans Affairs Medical Center - Milwaukee (Zablocki)Milwaukee, Wisconsin  53295
CCOP - EvanstonEvanston, Illinois  60201
CCOP - Geisinger Clinic and Medical CenterDanville, Pennsylvania  17822-2001
Veterans Affairs Medical Center - Lakeside ChicagoChicago, Illinois  60611
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland  21231-2410
Veterans Affairs Medical Center - New YorkNew York, New York  10010
CCOP - Marshfield Medical Research and Education FoundationMarshfield, Wisconsin  54449
CCOP - St. Vincent Hospital Cancer Center, Green BayGreen Bay, Wisconsin  54301
Evanston Northwestern Health CareEvanston, Illinois  60201
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
Veterans Affairs Medical Center - WichitaWichita, Kansas  67218
MBCCOP - LSU Health Sciences CenterNew Orleans, Louisiana  70112
Holden Comprehensive Cancer CenterIowa City, Iowa  52242-1009
CCOP - OklahomaTulsa, Oklahoma  74136
Veterans Affairs Medical Center - PittsburghPittsburgh, Pennsylvania  15240
Veterans Affairs Medical Center - MiamiMiami, Florida  33125
Cancer Institute of New JerseyNew Brunswick, New Jersey  08901
Veterans Affairs Medical Center - MinneapolisMinneapolis, Minnesota  55417
Veterans Affairs Medical Center - Palo AltoPalo Alto, California  94304
City of Hope Comprehensive Cancer CenterDuarte, California  91010
Albert Einstein Clinical Cancer CenterBronx, New York  10461
Veterans Affairs Medical Center - BrooklynBrooklyn, New York  11209
Veterans Affairs Medical Center - Tampa (Haley)Tampa, Florida  33612
Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville CampusNashville, Tennessee  37212
MBCCOP-Howard University Cancer CenterWashington, District of Columbia  20060
MBCCOP-Our Lady of Mercy Cancer CenterBronx, New York  10466
Veterans Affairs Medical Center - GainesvilleGainesville, Florida  32608-1197
Burgess Health CenterOnawa, Iowa  51040
Veterans Affairs Medical Center - OmahaOmaha, Nebraska  68105