Combination Chemotherapy Plus Fluoxetine in Treating Patients With Advanced or Recurrent Non-Small Cell Lung Cancer
- Conditions
- Anxiety DisorderFatigueLung CancerDepression
- Interventions
- Registration Number
- NCT00005850
- Lead Sponsor
- Alliance for Clinical Trials in Oncology
- Brief Summary
This trial is designed to test the efficacy of fluoxetine to improve patient's quality of life during chemotherapy. An innovative application of a selective serotonin reuptake inhibitor may modulate the effects of fatigue, anxiety and depression which worsen quality of life.
- Detailed Description
OBJECTIVES:
Primary Objectives:
1. To preliminarily test the efficacy of fluoxetine to improve the quality of life of patients with advanced non-small cell lung cancer receiving chemotherapy by decreasing anxiety, depression and fatigue.
2. To test the feasibility of conducting a multi-center clinical trial of fluoxetine administered by oncologists concurrently with chemotherapy in patients with non-small cell lung cancer.
Secondary Objectives:
1. To describe the tumor response rate associated with the administration of gemcitabine/cisplatin in patients with advanced non-small cell lung cancer.
2. To describe the overall survival and failure-free survival associated with the administration of gemcitabine/cisplatin.
3. To describe the toxicity associated with the administration of gemcitabine/cisplatin.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 21
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description gemcitabine + cisplatin + fluoxetine cisplatin Patients receive gemcitabine and cisplatin. Treatment repeats every 21 days for a total of six cycles. Patients receive fluoxetine for 7 weeks. Further use of fluoxetine is at the discretion of the patient and physician. gemcitabine + cisplatin + fluoxetine gemcitabine hydrochloride Patients receive gemcitabine and cisplatin. Treatment repeats every 21 days for a total of six cycles. Patients receive fluoxetine for 7 weeks. Further use of fluoxetine is at the discretion of the patient and physician. gemcitabine + cisplatin + fluoxetine fluoxetine Patients receive gemcitabine and cisplatin. Treatment repeats every 21 days for a total of six cycles. Patients receive fluoxetine for 7 weeks. Further use of fluoxetine is at the discretion of the patient and physician.
- Primary Outcome Measures
Name Time Method Change in the MHI-17 global psychological distress subscale Up to 8 weeks Overall survival Up to 2 years post-treatment Failure-free survival Up to 2 years post-treatment
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (43)
Memorial Regional Hospital Comprehensive Cancer Center
🇺🇸Hollywood, Florida, United States
Helen and Harry Gray Cancer Institute at Good Samaritan Medical Center
🇺🇸West Palm Beach, Florida, United States
Fort Wayne Medical Oncology and Hematology, Incorporated
🇺🇸Fort Wayne, Indiana, United States
Massachusetts General Hospital Cancer Center
🇺🇸Boston, Massachusetts, United States
Beth Israel Medical Center
🇺🇸Boston, Massachusetts, United States
Ellis Fischel Cancer Center - Columbia
🇺🇸Columbia, Missouri, United States
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
🇺🇸Syracuse, New York, United States
State University of New York - Upstate Medical University
🇺🇸Syracuse, New York, United States
Veterans Affairs Medical Center - Dallas
🇺🇸Dallas, Texas, United States
Lenoir Memorial Hospital Cancer Center
🇺🇸Kinston, North Carolina, United States
FirstHealth Moore Regional Hospital
🇺🇸Pinehurst, North Carolina, United States
Northeast Alabama Regional Medical Center
🇺🇸Anniston, Alabama, United States
Broward General Medical Center
🇺🇸Fort Lauderdale, Florida, United States
University of Chicago Cancer Research Center
🇺🇸Chicago, Illinois, United States
Virginia Oncology Associates - Norfolk
🇺🇸Norfolk, Virginia, United States
Veterans Affairs Medical Center - San Diego
🇺🇸San Diego, California, United States
Veterans Affairs Medical Center - Las Vegas
🇺🇸Las Vegas, Nevada, United States
Veterans Affairs Medical Center - Durham
🇺🇸Durham, North Carolina, United States
Barnes-Jewish Hospital
🇺🇸Saint Louis, Missouri, United States
University of Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
Louis A. Weiss Memorial Hospital
🇺🇸Chicago, Illinois, United States
Veterans Affairs Medical Center - Washington, DC
🇺🇸Washington, District of Columbia, United States
Saint Anthony Medical Center
🇺🇸Rockford, Illinois, United States
West Suburban Center for Cancer Care
🇺🇸River Forest, Illinois, United States
Veterans Affairs Medical Center - Baltimore
🇺🇸Baltimore, Maryland, United States
Lakeland Medical Center - St. Joseph
🇺🇸Saint Joseph, Michigan, United States
Cooper University Hospital
🇺🇸Camden, New Jersey, United States
Elmhurst Hospital Center
🇺🇸Elmhurst, New York, United States
Queens Cancer Center of Queens Hospital
🇺🇸Jamaica, New York, United States
Memorial Sloan-Kettering Cancer Center
🇺🇸New York, New York, United States
Veterans Affairs Medical Center - Syracuse
🇺🇸Syracuse, New York, United States
Veterans Affairs Medical Center - Asheville
🇺🇸Asheville, North Carolina, United States
Cape Fear Valley Health System
🇺🇸Fayetteville, North Carolina, United States
NorthEast Oncology Associates
🇺🇸Concord, North Carolina, United States
New Hanover Regional Medical Center
🇺🇸Wilmington, North Carolina, United States
Veterans Affairs Medical Center - Fargo
🇺🇸Fargo, North Dakota, United States
St. Mary's Medical Center
🇺🇸Huntington, West Virginia, United States
Martha Jefferson Hospital
🇺🇸Charlottesville, Virginia, United States
Oncology and Hematology Associates of Southwest Virginia, Inc.
🇺🇸Roanoke, Virginia, United States
Ministry Medical Group - Northern Region
🇺🇸Rhinelander, Wisconsin, United States
University of Puerto Rico School of Medicine Medical Sciences Campus
🇵🇷San Juan, Puerto Rico
Florida Hospital Cancer Institute
🇺🇸Orlando, Florida, United States
Baptist Hospital East - Louisville
🇺🇸Louisville, Kentucky, United States