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

Phase 2

Completed

• Conditions: Anxiety Disorder; Fatigue; Lung Cancer; Depression
• Interventions: Drug: cisplatin; Drug: fluoxetine; Drug: gemcitabine hydrochloride

• Registration Number: NCT00005850
• Lead Sponsor: Alliance for Clinical Trials in Oncology

Brief Summary

This trial is designed to test the efficacy of fluoxetine to improve patient's 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 gemcitabine/cisplatin in patients with advanced non-small cell lung cancer.

2. To describe the overall survival and failure-free survival associated with the administration of gemcitabine/cisplatin.

3. To describe the toxicity associated with the administration of gemcitabine/cisplatin.

Study Timeline

• Study First Submitted: 2000-06-02
• Study Start: 2001-08
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Primary Completion: 2003-09
• Study Completion: 2003-09
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-01
• Last Update Posted: 2016-07-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
gemcitabine + cisplatin + fluoxetine	cisplatin	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.
gemcitabine + cisplatin + fluoxetine	gemcitabine hydrochloride	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.
gemcitabine + cisplatin + fluoxetine	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.

Primary Outcome Measures

Name	Time	Method
Change in the MHI-17 global psychological distress subscale	Up to 8 weeks
Overall survival	Up to 2 years post-treatment
Failure-free survival	Up to 2 years post-treatment

Trial Locations

Locations (43)

Northeast Alabama Regional Medical Center; 🇺🇸 Anniston, Alabama, United States

Veterans Affairs Medical Center - San Diego; 🇺🇸 San Diego, California, United States

Veterans Affairs Medical Center - Washington, DC; 🇺🇸 Washington, District of Columbia, United States

Broward General Medical Center; 🇺🇸 Fort Lauderdale, Florida, United States

Memorial Regional Hospital Comprehensive Cancer Center; 🇺🇸 Hollywood, Florida, United States

Florida Hospital Cancer Institute; 🇺🇸 Orlando, Florida, United States

Helen and Harry Gray Cancer Institute at Good Samaritan Medical Center; 🇺🇸 West Palm Beach, Florida, United States

University of Chicago Cancer Research Center; 🇺🇸 Chicago, Illinois, United States

Louis A. Weiss Memorial Hospital; 🇺🇸 Chicago, Illinois, United States

West Suburban Center for Cancer Care; 🇺🇸 River Forest, Illinois, United States

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