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

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