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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



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