Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005850
Status:
COMPLETED
Last Update Posted:
2016-07-04
First Post:
2000-06-02
Brief Title:
Combination Chemotherapy Plus Fluoxetine in Treating Patients With Advanced or Recurrent Non-Small Cell Lung Cancer
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
Fluoxetine in Stage IIIBIV Non-Small Cell Lung Cancer NSCLC A Phase II Pilot Study to Improve Quality of Life During Chemotherapy
Status:
COMPLETED
Status Verified Date:
2016-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This trial is designed to test the efficacy of fluoxetine to improve patients quality of life during chemotherapy An innovative application of a selective serotonin reuptake inhibitor may modulate the effects of fatigue anxiety and depression which worsen quality of life
Detailed Description:
OBJECTIVES
Primary Objectives
1 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
2 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
Secondary Objectives
1 To describe the tumor response rate associated with the administration of gemcitabinecisplatin in patients with advanced non-small cell lung cancer
2 To describe the overall survival and failure-free survival associated with the administration of gemcitabinecisplatin
3 To describe the toxicity associated with the administration of gemcitabinecisplatin
Primary Objectives
1 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
2 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
Secondary Objectives
1 To describe the tumor response rate associated with the administration of gemcitabinecisplatin in patients with advanced non-small cell lung cancer
2 To describe the overall survival and failure-free survival associated with the administration of gemcitabinecisplatin
3 To describe the toxicity associated with the administration of gemcitabinecisplatin
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U10CA031946 | NIH | None | None |
| CLB-119802 | None | None | None |
| CDR0000067871 | REGISTRY | NCI Physician Data Query | httpsreporternihgovquickSearchU10CA031946 |