Fluoxetine in Stage IIIB/IV Non-Small Cell Lung Cancer (NSCLC): Phase II Pilot Study to Improve Quality of Life During Chemotherapy
OBJECTIVES:
- Determine the efficacy of fluoxetine in improving the quality of life by decreasing
anxiety, depression, and fatigue in patients with advanced or recurrent non-small cell
lung cancer when treated with gemcitabine and cisplatin.
- Determine the response rate, failure-free survival, and overall survival of patients
treated with gemcitabine and cisplatin.
- Assess the toxicity of gemcitabine and cisplatin in these patients.
OUTLINE: This is a multicenter study.
Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and cisplatin IV over 30
minutes (beginning after gemcitabine infusion) on day 1. Treatment repeats every 21 days for
6 courses in the absence of disease progression or unacceptable toxicity. Patients also
receive oral fluoxetine once daily on days 8-57. Patients may continue receiving fluoxetine
after day 57 at the discretion of the patient and physician.
Quality of life is assessed at baseline and then after receiving fluoxetine for 7 weeks
(days 57-61).
Patients are followed every 3 months for 2 years and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study within
approximately 9 months.
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
QOL
13 weeks
No
Donna Greenberg, MD
Study Chair
Massachusetts General Hospital
United States: Federal Government
CDR0000067871
NCT00005850
August 2001
Name | Location |
---|---|
Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
University of Chicago Cancer Research Center | Chicago, Illinois 60637 |
Ellis Fischel Cancer Center - Columbia | Columbia, Missouri 65203 |
Barnes-Jewish Hospital | Saint Louis, Missouri 63110 |
State University of New York - Upstate Medical University | Syracuse, New York 13210 |
Massachusetts General Hospital Cancer Center | Boston, Massachusetts 02114 |
Martha Jefferson Hospital | Charlottesville, Virginia 22901 |
Baptist Hospital East - Louisville | Louisville, Kentucky 40207 |
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C. | Syracuse, New York 13217 |
Veterans Affairs Medical Center - Fargo | Fargo, North Dakota 58102 |
Oncology and Hematology Associates of Southwest Virginia, Inc. | Roanoke, Virginia 24014 |
University of Nebraska Medical Center | Omaha, Nebraska 68198-3330 |
Veterans Affairs Medical Center - Syracuse | Syracuse, New York 13210 |
Veterans Affairs Medical Center - Durham | Durham, North Carolina 27705 |
Broward General Medical Center | Fort Lauderdale, Florida 33316 |
Florida Hospital Cancer Institute | Orlando, Florida 32804 |
Northeast Alabama Regional Medical Center | Anniston, Alabama 36207 |
Veterans Affairs Medical Center - San Diego | San Diego, California 92161 |
Veterans Affairs Medical Center - Washington, DC | Washington, District of Columbia 20422 |
Memorial Regional Hospital Comprehensive Cancer Center | Hollywood, Florida 33021 |
Helen and Harry Gray Cancer Institute at Good Samaritan Medical Center | West Palm Beach, Florida 33401 |
Louis A. Weiss Memorial Hospital | Chicago, Illinois 60640 |
West Suburban Center for Cancer Care | River Forest, Illinois 60305 |
Saint Anthony Medical Center | Rockford, Illinois 61108 |
Fort Wayne Medical Oncology and Hematology, Incorporated | Fort Wayne, Indiana 46885-5099 |
Veterans Affairs Medical Center - Baltimore | Baltimore, Maryland 21201 |
Lakeland Medical Center - St. Joseph | Saint Joseph, Michigan 49085 |
Veterans Affairs Medical Center - Las Vegas | Las Vegas, Nevada 89106 |
Cooper University Hospital | Camden, New Jersey 08103 |
Elmhurst Hospital Center | Elmhurst, New York 11373 |
Queens Cancer Center of Queens Hospital | Jamaica, New York 11432 |
Veterans Affairs Medical Center - Asheville | Asheville, North Carolina 28805 |
NorthEast Oncology Associates | Concord, North Carolina 28025 |
Cape Fear Valley Health System | Fayetteville, North Carolina 28302-2000 |
Lenoir Memorial Hospital Cancer Center | Kinston, North Carolina 28503-1678 |
FirstHealth Moore Regional Hospital | Pinehurst, North Carolina 28374 |
New Hanover Regional Medical Center | Wilmington, North Carolina 28402-9025 |
Veterans Affairs Medical Center - Dallas | Dallas, Texas 75216 |
Virginia Oncology Associates - Norfolk | Norfolk, Virginia 23502 |
St. Mary's Medical Center | Huntington, West Virginia 25701 |
Ministry Medical Group - Northern Region | Rhinelander, Wisconsin 54501 |
Beth Israel Medical Center | Boston, Massachusetts 02115 |