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



Status:Completed
Conditions:Lung Cancer, Lung Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - 120
Updated:1/3/2019
Start Date:August 2002
End Date:June 15, 2007

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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.

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.

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
We found this trial at
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Ann Arbor, Michigan 48106
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Baltimore, Maryland 21231
410-955-6190
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins The name Johns Hopkins has become synonymous...
2302
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Baltimore, MD
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330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
2578
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Boston, MA
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675 N Saint Clair St # 21-100
Chicago, Illinois 60611
(312) 695-1156
Robert H. Lurie Comprehensive Cancer Center at Northwestern University The cancer center was first established...
1730
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Chicago, IL
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2010 E 90th St
Cleveland, Ohio 44195
(866) 223-8100
Cleveland Clinic Taussig Cancer Center At Taussig Cancer Institute, more than 250 highly skilled doctors,...
2033
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Cleveland, OH
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1500 E Duarte Rd
Duarte, California 91010
(626) 256-4673
City of Hope Comprehensive Cancer Center City of Hope is a leading research and treatment...
4
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2220 Pierce Ave
Nashville, Tennessee 37232
615-936-8422
Vanderbilt-Ingram Cancer Center The Vanderbilt-Ingram Cancer Center, located in Nashville, Tenn., brings together the clinical...
1762
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Nashville, TN
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12902 USF Magnolia Dr
Tampa, Florida 33612
(888) 663-3488
H. Lee Moffitt Cancer Center & Research Institute Moffitt Cancer Center in Tampa, Florida, has...
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Atlanta, Georgia 30322
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Boston, Massachusetts 02111
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Cedar Rapids, Iowa 52403
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Cleveland, Ohio 44106
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1335 Dublin Road, Suite 124A
Columbus, Ohio 43215
(614) 488-2118
CCOP - Columbus As one of the original 20 CCOPs, the Columbus Community Clinical Oncology...
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Danville, Pennsylvania 17822
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Decatur, Illinois 62526
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Denver, CO
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300 East Locust St., Ste 350
Des Moines, Iowa 50309
(515) 244-7586
CCOP - Iowa Oncology Research Association The Iowa Oncology Research Association (IORA) was established by...
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400 E Third Street
Duluth, Minnesota 55805
(218) 786-3868
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East Orange, New Jersey 07018
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Evanston, Illinois 60201
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Evanston, Illinois 60201
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Fargo, North Dakota 58122
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Indianapolis, Indiana 46202
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Kalamazoo, Michigan 49007
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Lebanon, New Hampshire 03756
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8701 W Watertown Plank Rd
Milwaukee, Wisconsin
(414) 955-8296
Medical College of Wisconsin The Medical College (MCW) of Wisconsin is a major national research...
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533 Bolivar Street, Room 420
New Orleans, Louisiana 70112
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5150 Centre Ave
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Pittsburgh, Pennsylvania 15240
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200 First Street SW
Rochester, Minnesota 55905
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Saint Louis Park, Minnesota 55416
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Scottsdale, Arizona 85259
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300 Pasteur Dr
Stanford, California 94305
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Stanford Univ Med Ctr The Medical Center is uniquely advantaged by its location on the...
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Tulsa, Oklahoma 74136
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509 W. University Avenue
Urbana, Illinois 61801
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Washington, District of Columbia 20060
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