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Home > "C" Clinical Trials Conditions > Combination Chemotherapy Plus Fluoxetine in Treating Patients With Advanced or Recurrent Non-Small Cell Lung Cancer  Combination Chemotherapy Plus Fluoxetine in Treating Patients With Advanced or Recurrent Non-Small Cell Lung Cancer
Combination Chemotherapy Plus Fluoxetine in Treating Patients With Advanced or Recurrent Non-Small Cell Lung Cancer
For Condition: Anxiety Disorder,Fatigue,Depression,Non-small cell lung cancer
Status: Suspended
Sponsor(s): Cancer and Leukemia Group B , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one chemotherapy drug may kill more cancer cells. An antidepressant such as fluoxetine may improve the quality of life in patients undergoing chemotherapy. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus fluoxetine in treating patients who have advanced or recurrent non-small cell lung cancer.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed non-small cell carcinoma of the lung (adenocarcinoma, large cell, squamous, or any mixture of these types) - One of the following stages: - Stage IIIB - Malignant pleural effusion - Supraclavicular node involvement - Contralateral hilar nodes - Stage IV - Stage I-IIIA with recurrent or progressive disease after prior surgery or radiotherapy - At least 1 unidimensionally measurable lesion - At least 20 mm by conventional techniques OR - At least 10 mm by spiral CT scan - Non-measurable disease only allowed if there are concurrent ill-defined masses associated with post-obstructive changes and diffuse parenchymal malignant disease - Lesions that are considered non-measurable: - Bone lesions - Leptomeningeal disease - Ascites - Pleural/pericardial effusion - Abdominal masses not confirmed or followed by imaging - Cystic lesions - No known CNS metastases PATIENT CHARACTERISTICS: Age: - Not specified Performance status: - CTC 0-1 Life expectancy: - Not specified Hematopoietic: - Granulocyte count at least 1,500/mm3 - Platelet count at least 100,000/mm3 Hepatic: - Bilirubin no greater than 2 times upper limit of normal (ULN) - SGOT no greater than 2 times ULN Renal: - Creatinine no greater than 1.5 mg/dL OR - Creatinine clearance at least 60 mL/min Other: - Not pregnant or nursing - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - No prior chemotherapy - No other concurrent chemotherapy Endocrine therapy: - No concurrent steroids except for adrenal failure - No concurrent hormonal therapy except for nondisease-related conditions (e.g., insulin for diabetes) - Concurrent dexamethasone allowed as antiemetic if used intermittently Radiotherapy: - See Disease Characteristics - At least 2 weeks since prior radiotherapy - No concurrent radiotherapy, including for palliation Surgery: - See Disease Characteristics Other: - At least 1 month since prior antidepressant treatment (e.g., selective serotonin reuptake inhibitors, tricyclics, novel antidepressants, St. John's Wort, or monoamine oxidase inhibitors) - No other concurrent antidepressant treatment, including St. John's Wort - No concurrent codeine preparations for pain
Total Enrollment:
Location and Contact Information:
Overall Study Official:
DonnaGreenberg, Study Chair, Massachusetts General Hospital
Memorial Sloan-Kettering Cancer Center
New York City, New York, 10021
United States
Veterans Affairs Medical Center - Fargo
Fargo, North Dakota, 58102
United States
Elmhurst Hospital Center
Elmhurst, New York, 11373
United States
West Suburban Center for Cancer Care
River Forest, Illinois, 60305
United States
Queens Cancer Center of Queens Hospital
Jamaica, New York, 11432
United States
Ministry Medical Group - Northern Region
Rhinelander, Wisconsin, 54501
United States
University of Chicago Cancer Research Center
Chicago, Illinois, 60637-1470
United States
Martha Jefferson Hospital
Charlottesville, Virginia, 22901
United States
Veterans Affairs Medical Center - Baltimore
Baltimore, Maryland, 21201
United States
University of Puerto Rico School of Medicine Medical Sciences Campus
San Juan, , 00936-5067
Puerto Rico
Fort Wayne Medical Oncology and Hematology, Incorporated
Ft. Wayne, Indiana, 46885-5099
United States
Lakeland Medical Center - St. Joseph
Saint Joseph, Michigan, 49085
United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198-7680
United States
Cooper University Hospital
Camden, New Jersey, 08103
United States
Broward General Medical Center
Ft. Lauderdale, Florida, 33316
United States
Cape Fear Valley Health System
Fayetteville, North Carolina, 28302-2000
United States
Veterans Affairs Medical Center - Las Vegas
Las Vegas, Nevada, 89106
United States
Veterans Affairs Medical Center - San Diego
San Diego, California, 92161
United States
FirstHealth Moore Regional Hospital
Pinehurst, North Carolina, 28374
United States
Memorial Regional Hospital Comprehensive Cancer Center
Hollywood, Florida, 33021
United States
Oncology and Hematology Associates of Southwest Virginia, Inc.
Roanoke, Virginia, 24014
United States
Northeast Alabama Regional Medical Center
Anniston, Alabama, 36207
United States
Barnes-Jewish Hospital
St. Louis, Missouri, 63110
United States
Helen and Harry Gray Cancer Institute at Good Samaritan Medical Center
West Palm Beach, Florida, 33401
United States
Louis A. Weiss Memorial Hospital
Chicago, Illinois, 60640
United States
NorthEast Oncology Associates
Concord, North Carolina, 28025
United States
Veterans Affairs Medical Center - Dallas
Dallas, Texas, 75216
United States
Florida Hospital Cancer Institute
Orlando, Florida, 32804
United States
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
Syracuse, New York, 13217
United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114
United States
Virginia Oncology Associates - Norfolk
Norfolk, Virginia, 23502
United States
New Hanover Regional Medical Center
Wilmington, North Carolina, 28402-9025
United States
Veterans Affairs Medical Center - Asheville
Asheville, North Carolina, 28805
United States
Veterans Affairs Medical Center - Washington, DC
Washington D.C., District of Columbia, 20422
United States
St. Mary's Medical Center
Huntington, West Virginia, 25701
United States
Veterans Affairs Medical Center - Syracuse
Syracuse, New York, 13210
United States
Beth Israel Medical Center
Boston, Massachusetts, 02115
United States
Veterans Affairs Medical Center - Durham
Durham, North Carolina, 27705
United States
Saint Anthony Medical Center
Rockford, Illinois, 61108
United States
State University of New York - Upstate Medical University
Syracuse, New York, 13210
United States
Baptist Hospital East - Louisville
Louisville, Kentucky, 40207
United States
Ellis Fischel Cancer Center - Columbia
Columbia, Missouri, 65203
United States
Lenoir Memorial Hospital Cancer Center
Kinston, North Carolina, 28503-1678
United States
Additional Information:
Study ID Numbers: CDR0000067871; CLB-119802
Study Start Date:
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005850
Other Anxiety Disorder Studies:
1. Therapy for Depression with Co-occurring Panic or Anxiety Symptoms
2. Fear Conditioning Using Computer-Generated Virtual Reality
3. Gabapentin For the Control of Hot Flashes in Women With Breast Cancer
4. Stress Management Training in Patients Undergoing Radiation Therapy for Cancer
5. Music Therapy to Ease Pain and Emotional Distress in Patients With Hematologic Cancer Who Are Undergoing High-Dose Therapy and Stem Cell Transplantation
Related Studies:
Other Anxiety Disorder Clinical Trials
Other Illinois Clinical Trials
Other Chicago Clinical Trials
Combination Chemotherapy Plus Fluoxetine in Treating Patients With Advanced or Recurrent Non-Small Cell Lung Cancer
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