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Home > "C" Clinical Trials Conditions > Combination Chemotherapy in Treating Patients With Advanced Non-Small Cell Lung Cancer

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



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

For Condition: stage 3B non-small cell lung cancer,recurrent non-small cell lung cancer,stage 4 non-small cell lung cancer
Status: No longer recruiting
Sponsor(s): Eastern Cooperative Oncology Group , National Cancer Institute (NCI)
Synopsis: 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.
Details: 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.
Eligibility:
Study Type:
  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
GregoryMasters,  Study Chair,  Evanston Northwestern Health Care

Veterans Affairs Medical Center - Pittsburgh
Pittsburgh,  Pennsylvania,  15240-0001
United States
 

Stanford University Medical Center
Stanford,  California,  94305-5408
United States
 

CCOP - Geisinger Clinic and Medical Center
Danville,  Pennsylvania,  17822-2001
United States
 

Albert Einstein Clinical Cancer Center
Bronx,  New York,  10461
United States
 

Veterans Affairs Medical Center - Palo Alto
Palo Alto,  California,  94304-1290
United States
 

Emory University Hospital - Atlanta
Atlanta,  Georgia,  30322
United States
 

CCOP - Ochsner
New Orleans,  Louisiana,  70121
United States
 

Evanston Northwestern Health Care
Evanston,  Illinois,  60201
United States
 

CCOP - Northern New Jersey
Hackensack,  New Jersey,  07601
United States
 

Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville Campus
Nashville,  Tennessee,  37212-2637
United States
 

NYU School of Medicine's Kaplan Comprehensive Cancer Center
New York City,  New York,  10016
United States
 

City of Hope Comprehensive Cancer Center
Duarte,  California,  91010-3000
United States
 

Burgess Health Center
Onawa,  Iowa,  51040
United States
 

Cancer Institute of New Jersey
New Brunswick,  New Jersey,  08903
United States
 

Veterans Affairs Medical Center - Milwaukee (Zablocki)
Milwaukee,  Wisconsin,  53295
United States
 

Veterans Affairs Medical Center - Atlanta (Decatur)
Decatur,  Georgia,  30033
United States
 

Vanderbilt-Ingram Cancer Center
Nashville,  Tennessee,  37232-6307
United States
 

MBCCOP - San Juan
San Juan,  ,  00927-5800
Puerto Rico
 

Beth Israel Deaconess Medical Center
Boston,  Massachusetts,  02215
United States
 

CCOP - Merit Care Hospital
Fargo,  North Dakota,  58122
United States
 

Veterans Affairs Medical Center - Indianapolis (Roudebush)
Indianapolis,  Indiana,  46202
United States
 

CCOP - Christiana Care Health Services
Wilmington,  Delaware,  19899
United States
 

CCOP - Illinois Oncology Research Association
Peoria,  Illinois,  61602
United States
 

CCOP - Oklahoma
Tulsa,  Oklahoma,  74136
United States
 

CCOP - Iowa Oncology Research Association
Des Moines,  Iowa,  50309-1016
United States
 

CCOP - Southern Nevada Cancer Research Foundation
Las Vegas,  Nevada,  89106
United States
 

Veterans Affairs Medical Center - East Orange
East Orange,  New Jersey,  07019
United States
 

MBCCOP - LSU Health Sciences Center
New Orleans,  Louisiana,  70112
United States
 

CCOP - Missouri Valley Cancer Consortium
Omaha,  Nebraska,  68106
United States
 

Medical College of Wisconsin
Milwaukee,  Wisconsin,  53226-3596
United States
 

Ireland Cancer Center
Cleveland,  Ohio,  44106-5065
United States
 

CCOP - Ann Arbor Regional
Ann Arbor,  Michigan,  48106
United States
 

Veterans Affairs Medical Center - Wichita
Wichita,  Kansas,  67218
United States
 

CCOP - St. Vincent Hospital Cancer Center, Green Bay
Green Bay,  Wisconsin,  54301
United States
 

MBCCOP-Howard University Cancer Center
Washington D.C.,  District of Columbia,  20060
United States
 

Veterans Affairs Medical Center - Madison
Madison,  Wisconsin,  53705-2286
United States
 

H. Lee Moffitt Cancer Center and Research Institute
Tampa,  Florida,  33612-9497
United States
 

CCOP - Kalamazoo
Kalamazoo,  Michigan,  49007-3731
United States
 

CCOP - Sioux Community Cancer Consortium
Sioux Falls,  South Dakota,  57104
United States
 

Fox Chase Cancer Center
Philadelphia,  Pennsylvania,  19111
United States
 

University of Minnesota Cancer Center
Minneapolis,  Minnesota,  55455
United States
 

Pretoria Academic Hospitals
Pretoria,  ,  0001
South Africa
 

Veterans Affairs Medical Center - Miami
Miami,  Florida,  33125
United States
 

CCOP - Evanston
Evanston,  Illinois,  60201
United States
 

CCOP - Toledo Community Hospital Oncology Program
Toledo,  Ohio,  43623-3456
United States
 

CCOP - Marshfield Medical Research and Education Foundation
Marshfield,  Wisconsin,  54449
United States
 

CCOP - Columbus
Columbus,  Ohio,  43206
United States
 

Holden Comprehensive Cancer Center
Iowa City,  Iowa,  52242-1009
United States
 

Mayo Clinic Cancer Center
Rochester,  Minnesota,  55905
United States
 

CCOP - Wichita
Wichita,  Kansas,  67214-3882
United States
 

Hahnemann University Hospital
Philadelphia,  Pennsylvania,  19102-1192
United States
 

CCOP - Colorado Cancer Research Program, Inc.
Denver,  Colorado,  80224
United States
 

Veterans Affairs Medical Center - New York
New York City,  New York,  10010
United States
 

Veterans Affairs Medical Center - Tampa (Haley)
Tampa,  Florida,  33612
United States
 

CCOP - Carle Cancer Center
Urbana,  Illinois,  61801
United States
 

CCOP - Scottsdale Oncology Program
Scottsdale,  Arizona,  85259-5404
United States
 

Cleveland Clinic Taussig Cancer Center
Cleveland,  Ohio,  44195
United States
 

MBCCOP-Our Lady of Mercy Cancer Center
Bronx,  New York,  10466
United States
 

Norris Cotton Cancer Center
Lebanon,  New Hampshire,  03756-0002
United States
 

Veterans Affairs Medical Center - Gainesville
Gainesville,  Florida,  32608-1197
United States
 

University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham,  Alabama,  35294-3300
United States
 

University of Pittsburgh Cancer Institute
Pittsburgh,  Pennsylvania,  15213-3489
United States
 

CCOP - Metro-Minnesota
St. Louis Park,  Minnesota,  55416
United States
 

NSW Breast Cancer Institute
Westmead,  New South Wales,  2145
Australia
 

Veterans Affairs Medical Center - Omaha
Omaha,  Nebraska,  68105
United States
 

CCOP - Duluth
Duluth,  Minnesota,  55805
United States
 

Veterans Affairs Medical Center - Lakeside Chicago
Chicago,  Illinois,  60611-4494
United States
 

New England Medical Center Hospital
Boston,  Massachusetts,  02111
United States
 

Veterans Affairs Medical Center - Brooklyn
Brooklyn,  New York,  11209
United States
 

CCOP - Central Illinois
Decatur,  Illinois,  62526
United States
 

CCOP - MainLine Health
Wynnewood,  Pennsylvania,  19096
United States
 

CCOP - Cedar Rapids Oncology Project
Cedar Rapids,  Iowa,  52403-1206
United States
 

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore,  Maryland,  21231-2410
United States
 

University of Pennsylvania Cancer Center
Philadelphia,  Pennsylvania,  19104
United States
 

Indiana University Cancer Center
Indianapolis,  Indiana,  46202-5289
United States
 

Veterans Affairs Medical Center - Minneapolis
Minneapolis,  Minnesota,  55417-2399
United States
 

Veterans Affairs Medical Center - San Juan
San Juan,  ,  00927-5800
Puerto Rico
 

University of Wisconsin Comprehensive Cancer Center
Madison,  Wisconsin,  53792-0001
United States
 

Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago,  Illinois,  60611-3013
United States
 


Additional Information:
Study ID Numbers:
  CDR0000069467;  E-E1501
Study Start Date: 
Record last reviewed: April 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00041314

Other Stage 3b Non-Small Cell Lung Cancer Studies:
1. Paclitaxel in Treating Patients With Lung Cancer

2. Gemcitabine, Carboplatin, and Bortezomib in Treating Patients With Advanced or Recurrent Non-Small Cell Lung Cancer

3. Photodynamic Therapy Plus Brachytherapy in Treating Patients With Lung Cancer

4. ZD1839 Plus Combination Chemotherapy in Treating Patients With Non-Small Cell Lung Cancer

5. Hydroxyurea Plus Combination Chemotherapy in Patients With Non-small Cell Lung Cancer

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