Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Supportive care, Treatment	Closed	Not specified	NCI	CLB-119802 NCT00005850, CALGB-119802

Objectives

1. 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.
2. Determine the response rate, failure-free survival, and overall survival of patients treated with gemcitabine and cisplatin.
3. Assess the toxicity of gemcitabine and cisplatin in these patients.

Entry 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

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

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

Expected Enrollment

A total of 35 patients will be accrued for this study within approximately 9 months.

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.

Trial Contact Information

Trial Lead Organizations

Cancer and Leukemia Group B

Donna Greenberg, MD, Protocol chair		Ph: 617-726-8691; 877-726-5130

Registry Information
Official Title		Fluoxetine in Stage IIIB/IV Non-Small Cell Lung Cancer (NSCLC): Phase II Pilot Study to Improve Quality of Life During Chemotherapy
Trial Start Date		2001-08-15
Registered in ClinicalTrials.gov		NCT00005850
Date Submitted to PDQ		2000-04-11
Information Last Verified		2003-08-08
NCI Grant/Contract Number		CA31946

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