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

OBJECTIVES:

Primary Objectives:

• To preliminarily test the efficacy of fluoxetine to improve the quality of life of patients with advanced non-small cell lung cancer receiving chemotherapy by decreasing anxiety, depression and fatigue.
• To test the feasibility of conducting a multi-center clinical trial of fluoxetine administered by oncologists concurrently with chemotherapy in patients with non-small cell lung cancer.

Secondary Objectives:

• To describe the tumor response rate associated with the administration of gemcitabine/cisplatin in patients with advanced non-small cell lung cancer.
• To describe the overall survival and failure-free survival associated with the administration of gemcitabine/cisplatin.
• To describe the toxicity associated with the administration of gemcitabine/cisplatin.

Eligibility Criteria:

• Histologic Documentation: All patients must have histologically or cytologically documented, non-small cell carcinoma of the lung (adenocarcinoma, large cell, squamous, or mixtures of these types).
• Extent of Disease: Stage IIIB/IV cancer by the international staging system or any Stage I-IIIA otherwise eligible patient with recurrent or progressive NSCLC after surgery or radiotherapy.

• Patients with Stage IIIB because of a malignant pleural effusion, supraclavicular node involvement, or contralateral hilar nodes are eligible (IIIB patients eligible for CALGB protocols of combined chemotherapy and chest irradiation are not eligible.
• Patients with known CNS metastases are not eligible.
• Measurable or Non-Measurable Disease

• Measurable Disease: Lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 20 mm with conventional techniques or as ≥ 10 mm with spiral CT scan.
• Non-measurable Disease: Only those non-measurable disease patients with ill-defined masses associated with post-obstructive changes and diffuse parenchymal malignant disease are eligible. All other lesions, including small lesions (longest diameter < 20 mm with conventional techniques or < 10 mm with spiral CT scan) and truly non-measurable lesions, are not eligible.

Lesions that are considered non-measurable include the following:

• Bone lesions
• Leptomeningeal disease
• Ascites
• Pleural/pericardial effusion
• Abdominal masses that are not confirmed and followed by imaging techniques
• Cystic lesions
• Prior Treatment:

• No prior chemotherapy.
• ≥ 2 weeks since radiation therapy.
• No antidepressant treatment (eg, selective serotonin reuptake inhibitors, tricyclics, novel antidepressants, St. John's Wort or monoamine oxidase inhibitors) currently or within the last month.
• If the patient requires pain medication, pain must be managed with non-codeine preparations, including but not limited to: acetaminophen, any morphine based preparation (short or long acting), hydromorphone, fentanyl, levorphanol or methadone.
• CTC Performance Status 0-1.
• Non-pregnant and non-nursing because of significant risk to the fetus/infant.
• Required Initial Laboratory Data:

• Granulocytes ≥ 1,500/µl
• Platelet count ≥ 100,000/µl
• Serum creatinine ≤ 1.5 mg/dl or Calculated CrCl ≥ 60 ml/min
• Bilirubin ≤ 2.0 x Upper Limit of Normal (ULN)
• Serum glutamic oxaloacetic transaminase (SGOT) ≤ 2.0 x ULN