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| Sponsor: | Cancer and Leukemia Group B |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00005850 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Anxiety Disorder Depression Fatigue Lung Cancer |
Drug: cisplatin Drug: fluoxetine Drug: gemcitabine hydrochloride |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | Fluoxetine in Stage IIIB/IV Non-Small Cell Lung Cancer (NSCLC): Phase II Pilot Study to Improve Quality of Life During Chemotherapy |
| Study Start Date: | August 2001 |
| Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
At least 1 unidimensionally measurable lesion
Lesions that are considered non-measurable:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations
Show 43 Study Locations| Study Chair: | Donna Greenberg, MD | Massachusetts General Hospital |
More Information
| Study ID Numbers: | CDR0000067871, CLB-119802 |
| Study First Received: | June 2, 2000 |
| Last Updated: | September 10, 2009 |
| ClinicalTrials.gov Identifier: | NCT00005850 History of Changes |
| Health Authority: | United States: Federal Government |
|
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 |
|
Antimetabolites Thoracic Neoplasms Anti-Infective Agents Neurotransmitter Agents Neurotransmitter Uptake Inhibitors Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Psychotropic Drugs Signs and Symptoms Neoplasms by Site Pathologic Processes Respiratory Tract Diseases |
Cisplatin Mental Disorders Lung Neoplasms Therapeutic Uses Antidepressive Agents, Second-Generation Gemcitabine Antidepressive Agents Respiratory Tract Neoplasms Neoplasms by Histologic Type Fatigue Disease Depression Enzyme Inhibitors Depressive Disorder Immunosuppressive Agents |