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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
N/A
N/A
Not Enrolling
Both
Anxiety Disorder, Depression, Fatigue, Lung Cancer

Thank you

Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

QOL

Outcome Time Frame:

13 weeks

Safety Issue:

No

Principal Investigator

Donna Greenberg, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Massachusetts General Hospital

Authority:

United States: Federal Government

Study ID:

CDR0000067871

NCT ID:

NCT00005850

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

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
University of Chicago Cancer Research CenterChicago, Illinois  60637
Ellis Fischel Cancer Center - ColumbiaColumbia, Missouri  65203
Barnes-Jewish HospitalSaint Louis, Missouri  63110
State University of New York - Upstate Medical UniversitySyracuse, New York  13210
Massachusetts General Hospital Cancer CenterBoston, Massachusetts  02114
Martha Jefferson HospitalCharlottesville, Virginia  22901
Baptist Hospital East - LouisvilleLouisville, Kentucky  40207
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.Syracuse, New York  13217
Veterans Affairs Medical Center - FargoFargo, North Dakota  58102
Oncology and Hematology Associates of Southwest Virginia, Inc.Roanoke, Virginia  24014
University of Nebraska Medical CenterOmaha, Nebraska  68198-3330
Veterans Affairs Medical Center - SyracuseSyracuse, New York  13210
Veterans Affairs Medical Center - DurhamDurham, North Carolina  27705
Broward General Medical CenterFort Lauderdale, Florida  33316
Florida Hospital Cancer InstituteOrlando, Florida  32804
Northeast Alabama Regional Medical CenterAnniston, Alabama  36207
Veterans Affairs Medical Center - San DiegoSan Diego, California  92161
Veterans Affairs Medical Center - Washington, DCWashington, District of Columbia  20422
Memorial Regional Hospital Comprehensive Cancer CenterHollywood, Florida  33021
Helen and Harry Gray Cancer Institute at Good Samaritan Medical CenterWest Palm Beach, Florida  33401
Louis A. Weiss Memorial HospitalChicago, Illinois  60640
West Suburban Center for Cancer CareRiver Forest, Illinois  60305
Saint Anthony Medical CenterRockford, Illinois  61108
Fort Wayne Medical Oncology and Hematology, IncorporatedFort Wayne, Indiana  46885-5099
Veterans Affairs Medical Center - BaltimoreBaltimore, Maryland  21201
Lakeland Medical Center - St. JosephSaint Joseph, Michigan  49085
Veterans Affairs Medical Center - Las VegasLas Vegas, Nevada  89106
Cooper University HospitalCamden, New Jersey  08103
Elmhurst Hospital CenterElmhurst, New York  11373
Queens Cancer Center of Queens HospitalJamaica, New York  11432
Veterans Affairs Medical Center - AshevilleAsheville, North Carolina  28805
NorthEast Oncology AssociatesConcord, North Carolina  28025
Cape Fear Valley Health SystemFayetteville, North Carolina  28302-2000
Lenoir Memorial Hospital Cancer CenterKinston, North Carolina  28503-1678
FirstHealth Moore Regional HospitalPinehurst, North Carolina  28374
New Hanover Regional Medical CenterWilmington, North Carolina  28402-9025
Veterans Affairs Medical Center - DallasDallas, Texas  75216
Virginia Oncology Associates - NorfolkNorfolk, Virginia  23502
St. Mary's Medical CenterHuntington, West Virginia  25701
Ministry Medical Group - Northern RegionRhinelander, Wisconsin  54501
Beth Israel Medical CenterBoston, Massachusetts  02115