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Fluoxetine in Stage IIIB/IV Non-Small Cell Lung Cancer (NSCLC): Phase II Pilot Study to Improve Quality of Life During Chemotherapy

Phase 2
Not Enrolling
Anxiety Disorder, Depression, Fatigue, Lung Cancer

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Trial Information

Fluoxetine in Stage IIIB/IV Non-Small Cell Lung Cancer (NSCLC): Phase II Pilot Study to Improve Quality of Life During Chemotherapy


- 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.

Inclusion Criteria


- 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

- 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



- Not specified

Performance status:

- CTC 0-1

Life expectancy:

- Not specified


- Granulocyte count at least 1,500/mm3

- Platelet count at least 100,000/mm3


- Bilirubin no greater than 2 times upper limit of normal (ULN)

- SGOT no greater than 2 times ULN


- Creatinine no greater than 1.5 mg/dL OR

- Creatinine clearance at least 60 mL/min


- Not pregnant or nursing

- Fertile patients must use effective contraception


Biologic therapy:

- Not specified


- 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


- See Disease Characteristics

- At least 2 weeks since prior radiotherapy

- No concurrent radiotherapy, including for palliation


- See Disease Characteristics


- 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

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:


Outcome Time Frame:

13 weeks

Safety Issue:


Principal Investigator

Donna Greenberg, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Massachusetts General Hospital


United States: Federal Government

Study ID:




Start Date:

August 2001

Completion Date:

Related Keywords:

  • Anxiety Disorder
  • Depression
  • Fatigue
  • Lung Cancer
  • stage I non-small cell lung cancer
  • stage II non-small cell lung cancer
  • recurrent non-small cell lung cancer
  • squamous cell lung cancer
  • large cell lung cancer
  • stage IIIA non-small cell lung cancer
  • stage IIIB non-small cell lung cancer
  • stage IV non-small cell lung cancer
  • adenocarcinoma of the lung
  • adenosquamous cell lung cancer
  • fatigue
  • anxiety disorder
  • depression
  • Anxiety Disorders
  • Carcinoma, Non-Small-Cell Lung
  • Depression
  • Depressive Disorder
  • Fatigue
  • Lung Neoplasms



Memorial Sloan-Kettering Cancer Center New York, New York  10021
University of Chicago Cancer Research Center Chicago, Illinois  60637
Ellis Fischel Cancer Center - Columbia Columbia, Missouri  65203
Barnes-Jewish Hospital Saint Louis, Missouri  63110
State University of New York - Upstate Medical University Syracuse, New York  13210
Massachusetts General Hospital Cancer Center Boston, Massachusetts  02114
Martha Jefferson Hospital Charlottesville, Virginia  22901
Baptist Hospital East - Louisville Louisville, Kentucky  40207
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C. Syracuse, New York  13217
Veterans Affairs Medical Center - Fargo Fargo, North Dakota  58102
Oncology and Hematology Associates of Southwest Virginia, Inc. Roanoke, Virginia  24014
University of Nebraska Medical Center Omaha, Nebraska  68198-3330
Veterans Affairs Medical Center - Syracuse Syracuse, New York  13210
Veterans Affairs Medical Center - Durham Durham, North Carolina  27705
Broward General Medical Center Fort Lauderdale, Florida  33316
Florida Hospital Cancer Institute Orlando, Florida  32804
Northeast Alabama Regional Medical Center Anniston, Alabama  36207
Veterans Affairs Medical Center - San Diego San Diego, California  92161
Veterans Affairs Medical Center - Washington, DC Washington, District of Columbia  20422
Memorial Regional Hospital Comprehensive Cancer Center Hollywood, Florida  33021
Helen and Harry Gray Cancer Institute at Good Samaritan Medical Center West Palm Beach, Florida  33401
Louis A. Weiss Memorial Hospital Chicago, Illinois  60640
West Suburban Center for Cancer Care River Forest, Illinois  60305
Saint Anthony Medical Center Rockford, Illinois  61108
Fort Wayne Medical Oncology and Hematology, Incorporated Fort Wayne, Indiana  46885-5099
Veterans Affairs Medical Center - Baltimore Baltimore, Maryland  21201
Lakeland Medical Center - St. Joseph Saint Joseph, Michigan  49085
Veterans Affairs Medical Center - Las Vegas Las Vegas, Nevada  89106
Cooper University Hospital Camden, New Jersey  08103
Elmhurst Hospital Center Elmhurst, New York  11373
Queens Cancer Center of Queens Hospital Jamaica, New York  11432
Veterans Affairs Medical Center - Asheville Asheville, North Carolina  28805
NorthEast Oncology Associates Concord, North Carolina  28025
Cape Fear Valley Health System Fayetteville, North Carolina  28302-2000
Lenoir Memorial Hospital Cancer Center Kinston, North Carolina  28503-1678
FirstHealth Moore Regional Hospital Pinehurst, North Carolina  28374
New Hanover Regional Medical Center Wilmington, North Carolina  28402-9025
Veterans Affairs Medical Center - Dallas Dallas, Texas  75216
Virginia Oncology Associates - Norfolk Norfolk, Virginia  23502
St. Mary's Medical Center Huntington, West Virginia  25701
Ministry Medical Group - Northern Region Rhinelander, Wisconsin  54501
Beth Israel Medical Center Boston, Massachusetts  02115