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

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.

Study Type: Interventional

Study Design: Treatment

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.

Intervention(s) in this Clinical Trial

• Drug: cisplatin
• Drug: fluoxetine
• Drug: gemcitabine hydrochloride

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Cancer and Leukemia Group B

Overall Clinical Trial Officials and Contacts

Donna Greenberg, MD Study Chair Massachusetts General Hospital  

Information obtained from ClinicalTrials.gov on October 06, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00005850

Study ID Number: CDR0000067871

ClinicalTrials.gov Identifier: NCT00005850

Health Authority: United States: Federal Government

Clinical trial summary from the National Cancer Institute's PDQ® database