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.
- 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
- Assess the toxicity of gemcitabine and cisplatin in these patients.
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.
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
University of Puerto Rico School of Medicine Medical Sciences Campus, San Juan 00936-5067, Puerto Rico
Northeast Alabama Regional Medical Center, Anniston, Alabama 36207, United States
Veterans Affairs Medical Center - San Diego, San Diego, California 92161, United States
Veterans Affairs Medical Center - Washington, DC, Washington, District of Columbia 20422, United States
Broward General Medical Center, Fort Lauderdale, Florida 33316, United States
Florida Hospital Cancer Institute, Orlando, Florida 32804, United States
Helen and Harry Gray Cancer Institute at Good Samaritan Medical Center, West Palm Beach, Florida 33401, United States
Memorial Regional Hospital Comprehensive Cancer Center, Hollywood, Florida 33021, United States
Louis A. Weiss Memorial Hospital, Chicago, Illinois 60640, United States
Saint Anthony Medical Center, Rockford, Illinois 61108, United States
University of Chicago Cancer Research Center, Chicago, Illinois 60637-1470, United States
West Suburban Center for Cancer Care, River Forest, Illinois 60305, United States
Fort Wayne Medical Oncology and Hematology, Incorporated, Fort Wayne, Indiana 46885-5099, United States
Baptist Hospital East - Louisville, Louisville, Kentucky 40207, United States
Veterans Affairs Medical Center - Baltimore, Baltimore, Maryland 21201, United States
Beth Israel Medical Center, Boston, Massachusetts 02115, United States
Massachusetts General Hospital Cancer Center, Boston, Massachusetts 02114, United States
Lakeland Medical Center - St. Joseph, Saint Joseph, Michigan 49085, United States
Barnes-Jewish Hospital, Saint Louis, Missouri 63110, United States
Ellis Fischel Cancer Center - Columbia, Columbia, Missouri 65203, United States
University of Nebraska Medical Center, Omaha, Nebraska 68198-7680, United States
Veterans Affairs Medical Center - Las Vegas, Las Vegas, Nevada 89106, United States
Cooper University Hospital, Camden, New Jersey 08103, United States
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C., Syracuse, New York 13217, United States
Elmhurst Hospital Center, Elmhurst, New York 11373, United States
Memorial Sloan-Kettering Cancer Center, New York, New York 10021, United States
Queens Cancer Center of Queens Hospital, Jamaica, New York 11432, United States
State University of New York - Upstate Medical University, Syracuse, New York 13210, United States
Veterans Affairs Medical Center - Syracuse, Syracuse, New York 13210, United States
Cape Fear Valley Health System, Fayetteville, North Carolina 28302-2000, United States
FirstHealth Moore Regional Hospital, Pinehurst, North Carolina 28374, United States
Lenoir Memorial Hospital Cancer Center, Kinston, North Carolina 28503-1678, United States
New Hanover Regional Medical Center, Wilmington, North Carolina 28402-9025, United States
NorthEast Oncology Associates, Concord, North Carolina 28025, United States
Veterans Affairs Medical Center - Asheville, Asheville, North Carolina 28805, United States
Veterans Affairs Medical Center - Durham, Durham, North Carolina 27705, United States
Veterans Affairs Medical Center - Fargo, Fargo, North Dakota 58102, United States
Veterans Affairs Medical Center - Dallas, Dallas, Texas 75216, United States
Martha Jefferson Hospital, Charlottesville, Virginia 22901, United States
Oncology and Hematology Associates of Southwest Virginia, Inc., Roanoke, Virginia 24014, United States
Virginia Oncology Associates - Norfolk, Norfolk, Virginia 23502, United States
St. Mary's Medical Center, Huntington, West Virginia 25701, United States
Ministry Medical Group - Northern Region, Rhinelander, Wisconsin 54501, United States
