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Spots Global Cancer Trial Database for Combination Chemotherapy in Treating Patients With Recurrent or Refractory Small Cell Lung Cancer

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

Trial Identification

Brief Title: Combination Chemotherapy in Treating Patients With Recurrent or Refractory Small Cell Lung Cancer

Official Title: Phase II Trial of Gemcitabine/Irinotecan as Second Line Therapy for Small Cell Lung Cancer

Study ID: NCT00005972

Conditions

Lung Cancer

Study Description

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 combination chemotherapy in treating patients who have recurrent or refractory small cell lung cancer.

Detailed Description: OBJECTIVES: I. Determine the overall, complete, and partial response rates of patients with recurrent or refractory small cell lung cancer when treated with gemcitabine plus irinotecan. II. Determine the overall and failure free survival of these patients when treated with this regimen. III. Determine the duration of response of these patients after this treatment. IV. Evaluate the toxicity associated with the administration of this treatment in this patient population. OUTLINE: Patients are stratified according to prior response duration (progression 90 days or more after initial therapy vs progression less than 90 days after initial therapy or no response to initial therapy). Patients receive gemcitabine IV over 30 minutes and irinotecan IV over 90 minutes on days 1 and 8. Treatment continues every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 1 year, then every 6 months for 2 years, and then annually for 3 years. PROJECTED ACCRUAL: A total of 78 patients will be accrued for this study over 12-18 months.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Veterans Affairs Medical Center - Birmingham, Birmingham, Alabama, United States

University of California San Diego Cancer Center, La Jolla, California, United States

Veterans Affairs Medical Center - San Francisco, San Francisco, California, United States

UCSF Cancer Center and Cancer Research Institute, San Francisco, California, United States

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

Lombardi Cancer Center, Washington, District of Columbia, United States

Walter Reed Army Medical Center, Washington, District of Columbia, United States

CCOP - Mount Sinai Medical Center, Miami Beach, Florida, United States

University of Illinois at Chicago Health Sciences Center, Chicago, Illinois, United States

Veterans Affairs Medical Center - Chicago (Westside Hospital), Chicago, Illinois, United States

University of Chicago Cancer Research Center, Chicago, Illinois, United States

Hematology Oncology Associates of the Quad Cities, Bettendorf, Iowa, United States

Holden Comprehensive Cancer Center at The University of Iowa, Iowa City, Iowa, United States

Veterans Affairs Medical Center - Togus, Togus, Maine, United States

Marlene & Stewart Greenebaum Cancer Center, University of Maryland, Baltimore, Maryland, United States

Dana-Farber Cancer Institute, Boston, Massachusetts, United States

University of Massachusetts Memorial Medical Center, Worcester, Massachusetts, United States

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

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

Veterans Affairs Medical Center - Columbia (Truman Memorial), Columbia, Missouri, United States

Ellis Fischel Cancer Center - Columbia, Columbia, Missouri, United States

Barnes-Jewish Hospital, Saint Louis, Missouri, United States

University of Nebraska Medical Center, Omaha, Nebraska, United States

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

Norris Cotton Cancer Center, Lebanon, New Hampshire, United States

Veterans Affairs Medical Center - Buffalo, Buffalo, New York, United States

Roswell Park Cancer Institute, Buffalo, New York, United States

CCOP - North Shore University Hospital, Manhasset, New York, United States

North Shore University Hospital, Manhasset, New York, United States

Memorial Sloan-Kettering Cancer Center, New York, New York, United States

New York Presbyterian Hospital - Cornell Campus, New York, New York, United States

Mount Sinai Medical Center, NY, New York, New York, United States

State University of New York - Upstate Medical University, Syracuse, New York, United States

Veterans Affairs Medical Center - Syracuse, Syracuse, New York, United States

CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C., Syracuse, New York, United States

Lineberger Comprehensive Cancer Center, UNC, Chapel Hill, North Carolina, United States

Veterans Affairs Medical Center - Durham, Durham, North Carolina, United States

Duke Comprehensive Cancer Center, Durham, North Carolina, United States

CCOP - Southeast Cancer Control Consortium, Winston-Salem, North Carolina, United States

Comprehensive Cancer Center at Wake Forest University, Winston-Salem, North Carolina, United States

Arthur G. James Cancer Hospital - Ohio State University, Columbus, Ohio, United States

Rhode Island Hospital, Providence, Rhode Island, United States

Medical University of South Carolina, Charleston, South Carolina, United States

University of Tennessee, Memphis Cancer Center, Memphis, Tennessee, United States

Veterans Affairs Medical Center - Memphis, Memphis, Tennessee, United States

CCOP - Southwestern Vermont Regional Cancer Center, Bennington, Vermont, United States

Vermont Cancer Center, Burlington, Vermont, United States

Veterans Affairs Medical Center - White River Junction, White River Junction, Vermont, United States

Veterans Affairs Medical Center - Richmond, Richmond, Virginia, United States

MBCCOP - Massey Cancer Center, Richmond, Virginia, United States

Contact Details

Name: Caio Max Rocha Lima, MD

Affiliation: Medical University of South Carolina

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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