Combination Chemotherapy Plus Fluoxetine in Treating Patients With Advanced or Recurrent Non-Small Cell Lung Cancer
NCT ID: NCT00005850
Last Updated: 2016-07-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
21 participants
INTERVENTIONAL
2001-08-31
2003-09-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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gemcitabine + cisplatin + 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.
cisplatin
80 mg/m2 administered by intravenous (IV) over 30 minutes on Day 1 following the gemcitabine infusion. Treatment repeated every 21 days for a total of 6 cycles.
fluoxetine
10 mg PO QD (by mouth once daily) starting on week 2 (day 8) and continuing for 7 weeks (days 8-57). After 7 weeks of fluoxetine treatment (day 57), further use of fluoxetine is at the discretion of the patient and physician.
gemcitabine hydrochloride
1000 mg/m2 intravenous (IV) administered by IV over 30 minutes on days 1 and 8. Repeat treatment every 21 days for a total of 6 cycles.
Interventions
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cisplatin
80 mg/m2 administered by intravenous (IV) over 30 minutes on Day 1 following the gemcitabine infusion. Treatment repeated every 21 days for a total of 6 cycles.
fluoxetine
10 mg PO QD (by mouth once daily) starting on week 2 (day 8) and continuing for 7 weeks (days 8-57). After 7 weeks of fluoxetine treatment (day 57), further use of fluoxetine is at the discretion of the patient and physician.
gemcitabine hydrochloride
1000 mg/m2 intravenous (IV) administered by IV over 30 minutes on days 1 and 8. Repeat treatment every 21 days for a total of 6 cycles.
Eligibility Criteria
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Inclusion Criteria
* 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
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Alliance for Clinical Trials in Oncology
OTHER
Responsible Party
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Principal Investigators
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Donna Greenberg, MD
Role: STUDY_CHAIR
Massachusetts General Hospital
Locations
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Northeast Alabama Regional Medical Center
Anniston, Alabama, United States
Veterans Affairs Medical Center - San Diego
San Diego, California, United States
Veterans Affairs Medical Center - Washington, DC
Washington D.C., District of Columbia, United States
Broward General Medical Center
Fort Lauderdale, Florida, United States
Memorial Regional Hospital Comprehensive Cancer Center
Hollywood, Florida, United States
Florida Hospital Cancer Institute
Orlando, Florida, United States
Helen and Harry Gray Cancer Institute at Good Samaritan Medical Center
West Palm Beach, Florida, United States
University of Chicago Cancer Research Center
Chicago, Illinois, United States
Louis A. Weiss Memorial Hospital
Chicago, Illinois, United States
West Suburban Center for Cancer Care
River Forest, Illinois, United States
Saint Anthony Medical Center
Rockford, Illinois, United States
Fort Wayne Medical Oncology and Hematology, Incorporated
Fort Wayne, Indiana, United States
Baptist Hospital East - Louisville
Louisville, Kentucky, United States
Veterans Affairs Medical Center - Baltimore
Baltimore, Maryland, United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States
Beth Israel Medical Center
Boston, Massachusetts, United States
Lakeland Medical Center - St. Joseph
Saint Joseph, Michigan, United States
Ellis Fischel Cancer Center - Columbia
Columbia, Missouri, United States
Barnes-Jewish Hospital
St Louis, Missouri, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Veterans Affairs Medical Center - Las Vegas
Las Vegas, Nevada, 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
State University of New York - Upstate Medical University
Syracuse, New York, United States
Veterans Affairs Medical Center - Syracuse
Syracuse, New York, United States
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
Syracuse, New York, United States
Veterans Affairs Medical Center - Asheville
Asheville, North Carolina, United States
NorthEast Oncology Associates
Concord, North Carolina, United States
Veterans Affairs Medical Center - Durham
Durham, North Carolina, United States
Cape Fear Valley Health System
Fayetteville, North Carolina, United States
Lenoir Memorial Hospital Cancer Center
Kinston, North Carolina, United States
FirstHealth Moore Regional Hospital
Pinehurst, North Carolina, United States
New Hanover Regional Medical Center
Wilmington, North Carolina, United States
Veterans Affairs Medical Center - Fargo
Fargo, North Dakota, United States
Veterans Affairs Medical Center - Dallas
Dallas, Texas, United States
Martha Jefferson Hospital
Charlottesville, Virginia, United States
Virginia Oncology Associates - Norfolk
Norfolk, Virginia, United States
Oncology and Hematology Associates of Southwest Virginia, Inc.
Roanoke, Virginia, United States
St. Mary's Medical Center
Huntington, West 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
Countries
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Other Identifiers
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CLB-119802
Identifier Type: -
Identifier Source: secondary_id
CDR0000067871
Identifier Type: REGISTRY
Identifier Source: secondary_id
CALGB-119802
Identifier Type: -
Identifier Source: org_study_id
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