Lung Cancer Clinical Trial

S0119: Combination Chemotherapy in Treating Patients With Extensive-Stage Small Cell Lung Cancer

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 combination chemotherapy in treating patients who have extensive-stage small cell lung cancer.

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Full Description

OBJECTIVES:

Determine the survival of patients with extensive stage small cell lung cancer treated with gemcitabine and irinotecan.
Determine the response rates (confirmed and unconfirmed, complete and partial) of patients treated with this regimen.
Determine the overall toxic effects of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive gemcitabine IV over 30 minutes followed by irinotecan IV over 90 minutes on days 1 and 8. Treatment repeats every 21 days for a total of 6 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 75 patients will be accrued for this study within 12 months.

View Eligibility Criteria

Eligibility Criteria

DISEASE CHARACTERISTICS:

Histologically or cytologically confirmed extensive stage small cell lung cancer (SCLC)

Malignant pleural effusion constitutes extensive stage disease
Must have disease outside area of prior surgical resection or a new lesion must be present

Controlled brain metastases allowed (asymptomatic and previously treated with surgery and/or radiotherapy)

Brain metastases must be re-evaluated by CT scan or MRI after completion of radiotherapy or surgery

PATIENT CHARACTERISTICS:

Age:

18 and over

Performance status:

Zubrod 0-2

Life expectancy:

Not specified

Hematopoietic:

Absolute granulocyte count at least 1,500/mm^3
WBC at least 3,000/mm^3
Platelet count at least 100,000/mm^3

Hepatic:

Bilirubin no greater than 1.25 times upper limit of normal (ULN)
SGOT or SGPT no greater than 2.5 times ULN

Renal:

Not specified

Other:

Not pregnant or nursing
Fertile patients must use effective contraception
No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or other adequately treated stage I or II cancer in complete remission

PRIOR CONCURRENT THERAPY:

Biologic therapy:

No prior biologic therapy for SCLC

Chemotherapy:

No prior systemic chemotherapy for SCLC

Endocrine therapy:

Not specified

Radiotherapy:

See Disease Characteristics
No prior radiotherapy for SCLC except for brain metastases

Surgery:

See Disease Characteristics
At least 2 weeks since prior surgery (thoracic or other major surgery) and recovered

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

85

Study ID:

NCT00030433

Recruitment Status:

Completed

Sponsor:

Southwest Oncology Group

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There are 92 Locations for this study

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University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham Alabama, 35294, United States
MBCCOP - Gulf Coast
Mobile Alabama, 36688, United States
CCOP - Greater Phoenix
Phoenix Arizona, 85006, United States
Veterans Affairs Medical Center - Phoenix (Carl T. Hayden)
Phoenix Arizona, 85012, United States
Veterans Affairs Medical Center - Tucson
Tucson Arizona, 85723, United States
Arizona Cancer Center
Tucson Arizona, 85724, United States
University of Arkansas for Medical Sciences
Little Rock Arkansas, 72205, United States
Veterans Affairs Medical Center - Little Rock (McClellan)
Little Rock Arkansas, 72205, United States
City of Hope Comprehensive Cancer Center
Duarte California, 91010, United States
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles California, 90033, United States
Veterans Affairs Medical Center - West Los Angeles
Los Angeles California, 90073, United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles California, 90095, United States
Veterans Affairs Outpatient Clinic - Martinez
Martinez California, 94553, United States
CCOP - Bay Area Tumor Institute
Oakland California, 94609, United States
Chao Family Comprehensive Cancer Center
Orange California, 92868, United States
University of California Davis Medical Center
Sacramento California, 95817, United States
CCOP - Santa Rosa Memorial Hospital
Santa Rosa California, 95403, United States
David Grant Medical Center
Travis Air Force Base California, 94535, United States
University of Colorado Cancer Center
Denver Colorado, 80010, United States
Veterans Affairs Medical Center - Denver
Denver Colorado, 80220, United States
MBCCOP-Howard University Cancer Center
Washington District of Columbia, 20060, United States
CCOP - Atlanta Regional
Atlanta Georgia, 30342, United States
Dwight David Eisenhower Army Medical Center
Fort Gordon Georgia, 30905, United States
Cancer Research Center of Hawaii
Honolulu Hawaii, 96813, United States
Tripler Army Medical Center
Honolulu Hawaii, 96859, United States
MBCCOP - University of Illinois at Chicago
Chicago Illinois, 60612, United States
Veterans Affairs Medical Center - Chicago (Westside Hospital)
Chicago Illinois, 60612, United States
CCOP - Central Illinois
Decatur Illinois, 62526, United States
Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
Hines Illinois, 60141, United States
Loyola University Medical Center
Maywood Illinois, 60153, United States
University of Kansas Medical Center
Kansas City Kansas, 66160, United States
CCOP - Wichita
Wichita Kansas, 67214, United States
Veterans Affairs Medical Center - Wichita
Wichita Kansas, 67218, United States
Veterans Affairs Medical Center - Lexington
Lexington Kentucky, 40502, United States
Albert B. Chandler Medical Center, University of Kentucky
Lexington Kentucky, 40536, United States
MBCCOP - LSU Health Sciences Center
New Orleans Louisiana, 70112, United States
Tulane University School of Medicine
New Orleans Louisiana, 70112, United States
Veterans Affairs Medical Center - New Orleans
New Orleans Louisiana, 70112, United States
Louisiana State University Health Sciences Center - Shreveport
Shreveport Louisiana, 71130, United States
Veterans Affairs Medical Center - Shreveport
Shreveport Louisiana, 71130, United States
Boston Medical Center
Boston Massachusetts, 02118, United States
St. Elizabeth's Medical Center
Boston Massachusetts, 02135, United States
Veterans Affairs Medical Center - Boston (Jamaica Plain)
Jamaica Plain Massachusetts, 02130, United States
Veterans Affairs Medical Center - Ann Arbor
Ann Arbor Michigan, 48105, United States
CCOP - Ann Arbor Regional
Ann Arbor Michigan, 48106, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor Michigan, 48109, United States
Barbara Ann Karmanos Cancer Institute
Detroit Michigan, 48201, United States
Veterans Affairs Medical Center - Detroit
Detroit Michigan, 48201, United States
Henry Ford Hospital
Detroit Michigan, 48202, United States
CCOP - Grand Rapids Clinical Oncology Program
Grand Rapids Michigan, 49503, United States
CCOP - Beaumont
Royal Oak Michigan, 48073, United States
Providence Hospital - Southfield
Southfield Michigan, 48075, United States
CCOP - Duluth
Duluth Minnesota, 55805, United States
Veterans Affairs Medical Center - Biloxi
Biloxi Mississippi, 39531, United States
University of Mississippi Medical Center
Jackson Mississippi, 39216, United States
Veterans Affairs Medical Center - Jackson
Jackson Mississippi, 39216, United States
Keesler Medical Center - Keesler AFB
Keesler AFB Mississippi, 39534, United States
Veterans Affairs Medical Center - Kansas City
Kansas City Missouri, 64128, United States
CCOP - Kansas City
Kansas City Missouri, 64131, United States
St. Louis University Health Sciences Center
Saint Louis Missouri, 63110, United States
CCOP - St. Louis-Cape Girardeau
Saint Louis Missouri, 63141, United States
CCOP - Cancer Research for the Ozarks
Springfield Missouri, 65807, United States
CCOP - Montana Cancer Consortium
Billings Montana, 59101, United States
Veterans Affairs Medical Center - Albuquerque
Albuquerque New Mexico, 87108, United States
MBCCOP - University of New Mexico HSC
Albuquerque New Mexico, 87131, United States
Veterans Affairs Medical Center - Albany
Albany New York, 12208, United States
Herbert Irving Comprehensive Cancer Center
New York New York, 10032, United States
University of Rochester Medical Center
Rochester New York, 14642, United States
CCOP - Southeast Cancer Control Consortium
Winston-Salem North Carolina, 27104, United States
Veterans Affairs Medical Center - Cincinnati
Cincinnati Ohio, 45220, United States
Barrett Cancer Center
Cincinnati Ohio, 45267, United States
Cleveland Clinic Taussig Cancer Center
Cleveland Ohio, 44195, United States
CCOP - Columbus
Columbus Ohio, 43206, United States
Arthur G. James Cancer Hospital - Ohio State University
Columbus Ohio, 43210, United States
Veterans Affairs Medical Center - Dayton
Dayton Ohio, 45428, United States
CCOP - Dayton
Kettering Ohio, 45429, United States
Oklahoma Medical Research Foundation
Oklahoma City Oklahoma, 73104, United States
Veterans Affairs Medical Center - Oklahoma City
Oklahoma City Oklahoma, 73104, United States
Veterans Affairs Medical Center - Portland
Portland Oregon, 97207, United States
CCOP - Columbia River Program
Portland Oregon, 97225, United States
OHSU Cancer Institute
Portland Oregon, 97239, United States
Veterans Affairs Medical Center - Charleston
Charleston South Carolina, 29401, United States
Medical University of South Carolina
Charleston South Carolina, 29425, United States
CCOP - Greenville
Greenville South Carolina, 29615, United States
CCOP - Upstate Carolina
Spartanburg South Carolina, 29303, United States
Brooke Army Medical Center
Fort Sam Houston Texas, 78234, United States
University of Texas Medical Branch
Galveston Texas, 77555, United States
Baylor College of Medicine
Houston Texas, 77030, United States
Veterans Affairs Medical Center - Houston
Houston Texas, 77030, United States
Texas Tech University Health Science Center
Lubbock Texas, 79415, United States
University of Texas Health Science Center at San Antonio
San Antonio Texas, 78284, United States
Veterans Affairs Medical Center - San Antonio (Murphy)
San Antonio Texas, 78284, United States
Veterans Affairs Medical Center - Temple
Temple Texas, 76504, United States
CCOP - Scott and White Hospital
Temple Texas, 76508, United States
Huntsman Cancer Institute
Salt Lake City Utah, 84112, United States
Veterans Affairs Medical Center - Salt Lake City
Salt Lake City Utah, 84148, United States
Eastern Virginia Medical School
Norfolk Virginia, 23510, United States
CCOP - Virginia Mason Research Center
Seattle Washington, 98101, United States
Swedish Cancer Institute
Seattle Washington, 98104, United States
Veterans Affairs Medical Center - Seattle
Seattle Washington, 98108, United States
CCOP - Northwest
Tacoma Washington, 98405, United States
Madigan Army Medical Center
Tacoma Washington, 98431, United States

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

85

Study ID:

NCT00030433

Recruitment Status:

Completed

Sponsor:


Southwest Oncology Group

How clear is this clinincal trial information?

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