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Combination Chemotherapy Plus Fluoxetine in Treating Patients With Advanced or Recurrent Non-Small Cell Lung Cancer
This study has been completed.
First Received: June 2, 2000   Last Updated: September 10, 2009   History of Changes
Sponsor: Cancer and Leukemia Group B
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00005850
  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 II

Study Type: Interventional
Study Design: 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 National Cancer Institute (NCI):

Study Start Date: August 2001
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
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

  Show 43 Study Locations
Sponsors and Collaborators
Cancer and Leukemia Group B
Investigators
Study Chair: Donna Greenberg, MD Massachusetts General Hospital
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000067871, CLB-119802
Study First Received: June 2, 2000
Last Updated: September 10, 2009
ClinicalTrials.gov Identifier: NCT00005850     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
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:
Antimetabolites
Thoracic Neoplasms
Anti-Infective Agents
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Psychotropic Drugs
Signs and Symptoms
Neoplasms by Site
Pathologic Processes
Respiratory Tract Diseases
Cisplatin
Mental Disorders
Lung Neoplasms
Therapeutic Uses
Antidepressive Agents, Second-Generation
Gemcitabine
Antidepressive Agents
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Fatigue
Disease
Depression
Enzyme Inhibitors
Depressive Disorder
Immunosuppressive Agents

ClinicalTrials.gov processed this record on February 08, 2010