Combination Chemotherapy Plus Fluoxetine in Treating Patients With Advanced or Recurrent Non-Small Cell Lung Cancer

This study has been terminated.
(Lack of sufficient accrual)
Sponsor:
Collaborator:
Information provided by:
Cancer and Leukemia Group B
ClinicalTrials.gov Identifier:
NCT00005850
First received: June 2, 2000
Last updated: June 21, 2011
Last verified: June 2011
  Purpose

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.


Condition Intervention Phase
Anxiety Disorder
Depression
Fatigue
Lung Cancer
Drug: cisplatin
Drug: fluoxetine
Drug: gemcitabine hydrochloride
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Fluoxetine in Stage IIIB/IV Non-Small Cell Lung Cancer (NSCLC): Phase II Pilot Study to Improve Quality of Life During Chemotherapy

Resource links provided by NLM:


Further study details as provided by Cancer and Leukemia Group B:

Primary Outcome Measures:
  • QOL [ Time Frame: 13 weeks ] [ Designated as safety issue: No ]

Enrollment: 21
Study Start Date: August 2001
Primary Completion Date: September 2003 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: cisplatin
    80 mg/sq m IV Day 1 each cycle
    Drug: fluoxetine
    10 mg PO per day starting day 8
    Drug: gemcitabine hydrochloride
    1000 mg/sq m IV on days 1 and 8 of each cycle
Detailed Description:

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005850

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

No publications provided

Responsible Party: Monica M Bertagnolli, Cancer and Leukemia Group B
ClinicalTrials.gov Identifier: NCT00005850     History of Changes
Other Study ID Numbers: CDR0000067871, U10CA031946, CLB-119802
Study First Received: June 2, 2000
Last Updated: June 21, 2011
Health Authority: United States: Federal Government

Keywords provided by Cancer and Leukemia Group B:
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

Additional relevant MeSH terms:
Anxiety Disorders
Carcinoma, Non-Small-Cell Lung
Depression
Depressive Disorder
Fatigue
Lung Neoplasms
Mental Disorders
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Behavioral Symptoms
Mood Disorders
Signs and Symptoms
Gemcitabine
Cisplatin
Fluoxetine
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 19, 2013