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| Sponsors and Collaborators: |
Cancer and Leukemia Group B 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 |
| MedlinePlus related topics: | Anxiety Cancer Depression Lung Cancer |
| ChemIDplus related topics: | Cisplatin Gemcitabine hydrochloride Gemcitabine Fluoxetine Fluoxetine hydrochloride |
| 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 |
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 |
| Cancer and Leukemia Group B |
| National Cancer Institute (NCI) |
| Study Chair: | Donna Greenberg, MD | Massachusetts General Hospital |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
| Study ID Numbers: | CDR0000067871, CLB-119802 |
| First Received: | June 2, 2000 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00005850 |
| Health Authority: | United States: Federal Government |
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