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

Phase 2
Completed
Conditions
Lung Cancer
Registration Number
NCT00041314
Lead Sponsor
Eastern Cooperative Oncology Group
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.

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
Not specified
Inclusion Criteria

Not provided

Read More
Exclusion Criteria

Not provided

Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (79)

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

🇺🇸

Baltimore, Maryland, United States

Ireland Cancer Center

🇺🇸

Cleveland, Ohio, United States

Cleveland Clinic Taussig Cancer Center

🇺🇸

Cleveland, Ohio, United States

Beth Israel Deaconess Medical Center

🇺🇸

Boston, Massachusetts, United States

Veterans Affairs Medical Center - Indianapolis (Roudebush)

🇺🇸

Indianapolis, Indiana, United States

Veterans Affairs Medical Center - Minneapolis

🇺🇸

Minneapolis, Minnesota, United States

University of Minnesota Cancer Center

🇺🇸

Minneapolis, Minnesota, United States

CCOP - Southern Nevada Cancer Research Foundation

🇺🇸

Las Vegas, Nevada, United States

Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville Campus

🇺🇸

Nashville, Tennessee, United States

Vanderbilt-Ingram Cancer Center

🇺🇸

Nashville, Tennessee, United States

Veterans Affairs Medical Center - Wichita

🇺🇸

Wichita, Kansas, United States

Pretoria Academic Hospitals

🇿🇦

Pretoria, South Africa

CCOP - Marshfield Medical Research and Education Foundation

🇺🇸

Marshfield, Wisconsin, United States

CCOP - Geisinger Clinic and Medical Center

🇺🇸

Danville, Pennsylvania, United States

CCOP - Sioux Community Cancer Consortium

🇺🇸

Sioux Falls, South Dakota, United States

CCOP - Columbus

🇺🇸

Columbus, Ohio, United States

Hahnemann University Hospital

🇺🇸

Philadelphia, Pennsylvania, United States

CCOP - Oklahoma

🇺🇸

Tulsa, Oklahoma, United States

CCOP - Merit Care Hospital

🇺🇸

Fargo, North Dakota, United States

CCOP - MainLine Health

🇺🇸

Wynnewood, Pennsylvania, United States

University of Pittsburgh Cancer Institute

🇺🇸

Pittsburgh, Pennsylvania, United States

Veterans Affairs Medical Center - Pittsburgh

🇺🇸

Pittsburgh, Pennsylvania, United States

CCOP - Toledo Community Hospital Oncology Program

🇺🇸

Toledo, Ohio, United States

NYU School of Medicine's Kaplan Comprehensive Cancer Center

🇺🇸

New York, New York, United States

Mayo Clinic Cancer Center

🇺🇸

Rochester, Minnesota, United States

Veterans Affairs Medical Center - Omaha

🇺🇸

Omaha, Nebraska, United States

CCOP - Missouri Valley Cancer Consortium

🇺🇸

Omaha, Nebraska, United States

Medical College of Wisconsin

🇺🇸

Milwaukee, Wisconsin, United States

Veterans Affairs Medical Center - Milwaukee (Zablocki)

🇺🇸

Milwaukee, Wisconsin, United States

University of Alabama at Birmingham Comprehensive Cancer Center

🇺🇸

Birmingham, Alabama, United States

Indiana University Cancer Center

🇺🇸

Indianapolis, Indiana, United States

Norris Cotton Cancer Center

🇺🇸

Lebanon, New Hampshire, United States

CCOP - Scottsdale Oncology Program

🇺🇸

Scottsdale, Arizona, United States

City of Hope Comprehensive Cancer Center

🇺🇸

Duarte, California, United States

Stanford University Medical Center

🇺🇸

Stanford, California, United States

MBCCOP-Howard University Cancer Center

🇺🇸

Washington, District of Columbia, United States

CCOP - Christiana Care Health Services

🇺🇸

Wilmington, Delaware, United States

Veterans Affairs Medical Center - Gainesville

🇺🇸

Gainesville, Florida, United States

Robert H. Lurie Comprehensive Cancer Center, Northwestern University

🇺🇸

Chicago, Illinois, United States

Veterans Affairs Medical Center - Atlanta (Decatur)

🇺🇸

Decatur, Georgia, United States

Emory University Hospital - Atlanta

🇺🇸

Atlanta, Georgia, United States

Veterans Affairs Medical Center - Lakeside Chicago

🇺🇸

Chicago, Illinois, United States

CCOP - Central Illinois

🇺🇸

Decatur, Illinois, United States

CCOP - Evanston

🇺🇸

Evanston, Illinois, United States

Evanston Northwestern Health Care

🇺🇸

Evanston, Illinois, United States

CCOP - Illinois Oncology Research Association

🇺🇸

Peoria, Illinois, United States

CCOP - Carle Cancer Center

🇺🇸

Urbana, Illinois, United States

CCOP - Cedar Rapids Oncology Project

🇺🇸

Cedar Rapids, Iowa, United States

CCOP - Iowa Oncology Research Association

🇺🇸

Des Moines, Iowa, United States

Holden Comprehensive Cancer Center

🇺🇸

Iowa City, Iowa, United States

CCOP - Wichita

🇺🇸

Wichita, Kansas, United States

Burgess Health Center

🇺🇸

Onawa, Iowa, United States

New England Medical Center Hospital

🇺🇸

Boston, Massachusetts, United States

CCOP - Kalamazoo

🇺🇸

Kalamazoo, Michigan, United States

CCOP - Duluth

🇺🇸

Duluth, Minnesota, United States

CCOP - Metro-Minnesota

🇺🇸

Saint Louis Park, Minnesota, United States

MBCCOP-Our Lady of Mercy Cancer Center

🇺🇸

Bronx, New York, United States

Albert Einstein Clinical Cancer Center

🇺🇸

Bronx, New York, United States

Cancer Institute of New Jersey

🇺🇸

New Brunswick, New Jersey, United States

Veterans Affairs Medical Center - Brooklyn

🇺🇸

Brooklyn, New York, United States

CCOP - Northern New Jersey

🇺🇸

Hackensack, New Jersey, United States

Veterans Affairs Medical Center - New York

🇺🇸

New York, New York, United States

University of Pennsylvania Cancer Center

🇺🇸

Philadelphia, Pennsylvania, United States

Veterans Affairs Medical Center - Madison

🇺🇸

Madison, Wisconsin, United States

CCOP - St. Vincent Hospital Cancer Center, Green Bay

🇺🇸

Green Bay, Wisconsin, United States

University of Wisconsin Comprehensive Cancer Center

🇺🇸

Madison, Wisconsin, United States

NSW Breast Cancer Institute

🇦🇺

Westmead, New South Wales, Australia

MBCCOP - San Juan

🇵🇷

San Juan, Puerto Rico

Veterans Affairs Medical Center - San Juan

🇵🇷

San Juan, Puerto Rico

H. Lee Moffitt Cancer Center and Research Institute

🇺🇸

Tampa, Florida, United States

Veterans Affairs Medical Center - Tampa (Haley)

🇺🇸

Tampa, Florida, United States

CCOP - Ann Arbor Regional

🇺🇸

Ann Arbor, Michigan, United States

Veterans Affairs Medical Center - Palo Alto

🇺🇸

Palo Alto, California, United States

CCOP - Colorado Cancer Research Program, Inc.

🇺🇸

Denver, Colorado, United States

Veterans Affairs Medical Center - Miami

🇺🇸

Miami, Florida, United States

Fox Chase Cancer Center

🇺🇸

Philadelphia, Pennsylvania, United States

Veterans Affairs Medical Center - East Orange

🇺🇸

East Orange, New Jersey, United States

MBCCOP - LSU Health Sciences Center

🇺🇸

New Orleans, Louisiana, United States

CCOP - Ochsner

🇺🇸

New Orleans, Louisiana, United States

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