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.
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
Eligibility Criteria:
1. Histologic Documentation: All patients must have histologically or cytologically
documented, non-small cell carcinoma of the lung (adenocarcinoma, large cell,
squamous, or mixtures of these types).
2. Extent of Disease: Stage IIIB/IV cancer by the international staging system or any
Stage I-IIIA otherwise eligible patient with recurrent or progressive NSCLC after
surgery or radiotherapy.
- Patients with Stage IIIB because of a malignant pleural effusion,
supraclavicular node involvement, or contralateral hilar nodes are eligible
(IIIB patients eligible for CALGB protocols of combined chemotherapy and chest
irradiation are not eligible.
- Patients with known CNS metastases are not eligible.
3. Measurable or Non-Measurable Disease
- Measurable Disease: Lesions that can be accurately measured in at least one
dimension (longest diameter to be recorded) as ≥ 20 mm with conventional
techniques or as ≥ 10 mm with spiral CT scan.
- Non-measurable Disease: Only those non-measurable disease patients with
ill-defined masses associated with post-obstructive changes and diffuse
parenchymal malignant disease are eligible. All other lesions, including small
lesions (longest diameter < 20 mm with conventional techniques or < 10 mm with
spiral CT scan) and truly non-measurable lesions, are not eligible.
Lesions that are considered non-measurable include the following:
- Bone lesions
- Leptomeningeal disease
- Ascites
- Pleural/pericardial effusion
- Abdominal masses that are not confirmed and followed by imaging techniques
- Cystic lesions
4. Prior Treatment:
- No prior chemotherapy.
- ≥ 2 weeks since radiation therapy.
- No antidepressant treatment (eg, selective serotonin reuptake inhibitors,
tricyclics, novel antidepressants, St. John's Wort or monoamine oxidase
inhibitors) currently or within the last month.
5. If the patient requires pain medication, pain must be managed with non-codeine
preparations, including but not limited to: acetaminophen, any morphine based
preparation (short or long acting), hydromorphone, fentanyl, levorphanol or
methadone.
6. CTC Performance Status 0-1.
7. Non-pregnant and non-nursing because of significant risk to the fetus/infant.
8. Required Initial Laboratory Data:
- Granulocytes ≥ 1,500/µl
- Platelet count ≥ 100,000/µl
- Serum creatinine ≤ 1. 5 mg/dl or Calculated CrCl ≥ 60 ml/min
- Bilirubin ≤ 2. 0 x Upper Limit of Normal (ULN)
- Serum glutamic oxaloacetic transaminase (SGOT) ≤ 2. 0 x ULN
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
Memorial Regional Hospital Comprehensive Cancer Center, Hollywood, Florida 33021, 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
Louis A. Weiss Memorial Hospital, Chicago, Illinois 60640, 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
Saint Anthony Medical Center, Rockford, Illinois 61108, 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
Ellis Fischel Cancer Center - Columbia, Columbia, Missouri 65203, United States
Barnes-Jewish Hospital, Saint Louis, Missouri 63110, 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
Elmhurst Hospital Center, Elmhurst, New York 11373, United States
Queens Cancer Center of Queens Hospital, Jamaica, New York 11432, United States
Memorial Sloan-Kettering Cancer Center, New York, New York 10021, United States
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C., Syracuse, New York 13217, 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
Veterans Affairs Medical Center - Asheville, Asheville, North Carolina 28805, United States
NorthEast Oncology Associates, Concord, North Carolina 28025, United States
Veterans Affairs Medical Center - Durham, Durham, North Carolina 27705, United States
Cape Fear Valley Health System, Fayetteville, North Carolina 28302-2000, United States
Lenoir Memorial Hospital Cancer Center, Kinston, North Carolina 28503-1678, United States
FirstHealth Moore Regional Hospital, Pinehurst, North Carolina 28374, United States
New Hanover Regional Medical Center, Wilmington, North Carolina 28402-9025, 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
Virginia Oncology Associates - Norfolk, Norfolk, Virginia 23502, United States
Oncology and Hematology Associates of Southwest Virginia, Inc., Roanoke, Virginia 24014, United States
St. Mary's Medical Center, Huntington, West Virginia 25701, United States
Ministry Medical Group - Northern Region, Rhinelander, Wisconsin 54501, United States