Combination Chemotherapy Plus Fluoxetine in Treating Patients With Advanced or Recurrent Non-Small Cell Lung Cancer
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|ClinicalTrials.gov Identifier: NCT00005850|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : July 4, 2016
|Condition or disease||Intervention/treatment||Phase|
|Anxiety Disorder Depression Fatigue Lung Cancer||Drug: cisplatin Drug: fluoxetine Drug: gemcitabine hydrochloride||Phase 2|
- 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.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||21 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Fluoxetine in Stage IIIB/IV Non-Small Cell Lung Cancer (NSCLC): A Phase II Pilot Study to Improve Quality of Life During Chemotherapy|
|Study Start Date :||August 2001|
|Primary Completion Date :||September 2003|
|Study Completion Date :||September 2003|
U.S. FDA Resources
Experimental: gemcitabine + cisplatin + fluoxetine
Patients receive gemcitabine and cisplatin. Treatment repeats every 21 days for a total of six cycles. Patients receive fluoxetine for 7 weeks. Further use of fluoxetine is at the discretion of the patient and physician.
80 mg/m2 administered by intravenous (IV) over 30 minutes on Day 1 following the gemcitabine infusion. Treatment repeated every 21 days for a total of 6 cycles.Drug: fluoxetine
10 mg PO QD (by mouth once daily) starting on week 2 (day 8) and continuing for 7 weeks (days 8-57). After 7 weeks of fluoxetine treatment (day 57), further use of fluoxetine is at the discretion of the patient and physician.Drug: gemcitabine hydrochloride
1000 mg/m2 intravenous (IV) administered by IV over 30 minutes on days 1 and 8. Repeat treatment every 21 days for a total of 6 cycles.
- Change in the MHI-17 global psychological distress subscale [ Time Frame: Up to 8 weeks ]
- Overall survival [ Time Frame: Up to 2 years post-treatment ]
- Failure-free survival [ Time Frame: Up to 2 years post-treatment ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00005850
Show 43 Study Locations
|Study Chair:||Donna Greenberg, MD||Massachusetts General Hospital|