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

Primary Purpose

Anxiety Disorder, Depression, Fatigue

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
cisplatin
fluoxetine
gemcitabine hydrochloride
Sponsored by
Alliance for Clinical Trials in Oncology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety Disorder focused on measuring 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

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Eligibility Criteria: Histologic Documentation: All patients must have histologically or cytologically documented, non-small cell carcinoma of the lung (adenocarcinoma, large cell, squamous, or mixtures of these types). Extent of Disease: Stage IIIB/IV cancer by the international staging system or any Stage I-IIIA otherwise eligible patient with recurrent or progressive NSCLC after surgery or radiotherapy. Patients with Stage IIIB because of a malignant pleural effusion, supraclavicular node involvement, or contralateral hilar nodes are eligible (IIIB patients eligible for CALGB protocols of combined chemotherapy and chest irradiation are not eligible. Patients with known CNS metastases are not eligible. Measurable or Non-Measurable Disease Measurable Disease: Lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 20 mm with conventional techniques or as ≥ 10 mm with spiral CT scan. Non-measurable Disease: Only those non-measurable disease patients with ill-defined masses associated with post-obstructive changes and diffuse parenchymal malignant disease are eligible. All other lesions, including small lesions (longest diameter < 20 mm with conventional techniques or < 10 mm with spiral CT scan) and truly non-measurable lesions, are not eligible. Lesions that are considered non-measurable include the following: Bone lesions Leptomeningeal disease Ascites Pleural/pericardial effusion Abdominal masses that are not confirmed and followed by imaging techniques Cystic lesions Prior Treatment: No prior chemotherapy. ≥ 2 weeks since radiation therapy. No antidepressant treatment (eg, selective serotonin reuptake inhibitors, tricyclics, novel antidepressants, St. John's Wort or monoamine oxidase inhibitors) currently or within the last month. If the patient requires pain medication, pain must be managed with non-codeine preparations, including but not limited to: acetaminophen, any morphine based preparation (short or long acting), hydromorphone, fentanyl, levorphanol or methadone. CTC Performance Status 0-1. Non-pregnant and non-nursing because of significant risk to the fetus/infant. Required Initial Laboratory Data: Granulocytes ≥ 1,500/µl Platelet count ≥ 100,000/µl Serum creatinine ≤ 1.5 mg/dl or Calculated CrCl ≥ 60 ml/min Bilirubin ≤ 2.0 x Upper Limit of Normal (ULN) Serum glutamic oxaloacetic transaminase (SGOT) ≤ 2.0 x ULN

Sites / Locations

  • Northeast Alabama Regional Medical Center
  • Veterans Affairs Medical Center - San Diego
  • Veterans Affairs Medical Center - Washington, DC
  • Broward General Medical Center
  • Memorial Regional Hospital Comprehensive Cancer Center
  • Florida Hospital Cancer Institute
  • Helen and Harry Gray Cancer Institute at Good Samaritan Medical Center
  • University of Chicago Cancer Research Center
  • Louis A. Weiss Memorial Hospital
  • West Suburban Center for Cancer Care
  • Saint Anthony Medical Center
  • Fort Wayne Medical Oncology and Hematology, Incorporated
  • Baptist Hospital East - Louisville
  • Veterans Affairs Medical Center - Baltimore
  • Massachusetts General Hospital Cancer Center
  • Beth Israel Medical Center
  • Lakeland Medical Center - St. Joseph
  • Ellis Fischel Cancer Center - Columbia
  • Barnes-Jewish Hospital
  • University of Nebraska Medical Center
  • Veterans Affairs Medical Center - Las Vegas
  • Cooper University Hospital
  • Elmhurst Hospital Center
  • Queens Cancer Center of Queens Hospital
  • Memorial Sloan-Kettering Cancer Center
  • State University of New York - Upstate Medical University
  • Veterans Affairs Medical Center - Syracuse
  • CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
  • Veterans Affairs Medical Center - Asheville
  • NorthEast Oncology Associates
  • Veterans Affairs Medical Center - Durham
  • Cape Fear Valley Health System
  • Lenoir Memorial Hospital Cancer Center
  • FirstHealth Moore Regional Hospital
  • New Hanover Regional Medical Center
  • Veterans Affairs Medical Center - Fargo
  • Veterans Affairs Medical Center - Dallas
  • Martha Jefferson Hospital
  • Virginia Oncology Associates - Norfolk
  • Oncology and Hematology Associates of Southwest Virginia, Inc.
  • St. Mary's Medical Center
  • Ministry Medical Group - Northern Region
  • University of Puerto Rico School of Medicine Medical Sciences Campus

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

gemcitabine + cisplatin + fluoxetine

Arm Description

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.

Outcomes

Primary Outcome Measures

Change in the MHI-17 global psychological distress subscale
Overall survival
Failure-free survival

Secondary Outcome Measures

Full Information

First Posted
June 2, 2000
Last Updated
July 1, 2016
Sponsor
Alliance for Clinical Trials in Oncology
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00005850
Brief Title
Combination Chemotherapy Plus Fluoxetine in Treating Patients With Advanced or Recurrent Non-Small Cell Lung Cancer
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 Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
August 2001 (undefined)
Primary Completion Date
September 2003 (Actual)
Study Completion Date
September 2003 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alliance for Clinical Trials in Oncology
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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: 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. Secondary Objectives: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety Disorder, Depression, Fatigue, Lung Cancer
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
gemcitabine + cisplatin + fluoxetine
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
cisplatin
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
fluoxetine
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
gemcitabine hydrochloride
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in the MHI-17 global psychological distress subscale
Time Frame
Up to 8 weeks
Title
Overall survival
Time Frame
Up to 2 years post-treatment
Title
Failure-free survival
Time Frame
Up to 2 years post-treatment

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Eligibility Criteria: Histologic Documentation: All patients must have histologically or cytologically documented, non-small cell carcinoma of the lung (adenocarcinoma, large cell, squamous, or mixtures of these types). Extent of Disease: Stage IIIB/IV cancer by the international staging system or any Stage I-IIIA otherwise eligible patient with recurrent or progressive NSCLC after surgery or radiotherapy. Patients with Stage IIIB because of a malignant pleural effusion, supraclavicular node involvement, or contralateral hilar nodes are eligible (IIIB patients eligible for CALGB protocols of combined chemotherapy and chest irradiation are not eligible. Patients with known CNS metastases are not eligible. Measurable or Non-Measurable Disease Measurable Disease: Lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 20 mm with conventional techniques or as ≥ 10 mm with spiral CT scan. Non-measurable Disease: Only those non-measurable disease patients with ill-defined masses associated with post-obstructive changes and diffuse parenchymal malignant disease are eligible. All other lesions, including small lesions (longest diameter < 20 mm with conventional techniques or < 10 mm with spiral CT scan) and truly non-measurable lesions, are not eligible. Lesions that are considered non-measurable include the following: Bone lesions Leptomeningeal disease Ascites Pleural/pericardial effusion Abdominal masses that are not confirmed and followed by imaging techniques Cystic lesions Prior Treatment: No prior chemotherapy. ≥ 2 weeks since radiation therapy. No antidepressant treatment (eg, selective serotonin reuptake inhibitors, tricyclics, novel antidepressants, St. John's Wort or monoamine oxidase inhibitors) currently or within the last month. If the patient requires pain medication, pain must be managed with non-codeine preparations, including but not limited to: acetaminophen, any morphine based preparation (short or long acting), hydromorphone, fentanyl, levorphanol or methadone. CTC Performance Status 0-1. Non-pregnant and non-nursing because of significant risk to the fetus/infant. Required Initial Laboratory Data: Granulocytes ≥ 1,500/µl Platelet count ≥ 100,000/µl Serum creatinine ≤ 1.5 mg/dl or Calculated CrCl ≥ 60 ml/min Bilirubin ≤ 2.0 x Upper Limit of Normal (ULN) Serum glutamic oxaloacetic transaminase (SGOT) ≤ 2.0 x ULN
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Donna Greenberg, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Northeast Alabama Regional Medical Center
City
Anniston
State/Province
Alabama
ZIP/Postal Code
36207
Country
United States
Facility Name
Veterans Affairs Medical Center - San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92161
Country
United States
Facility Name
Veterans Affairs Medical Center - Washington, DC
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20422
Country
United States
Facility Name
Broward General Medical Center
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33316
Country
United States
Facility Name
Memorial Regional Hospital Comprehensive Cancer Center
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
Florida Hospital Cancer Institute
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States
Facility Name
Helen and Harry Gray Cancer Institute at Good Samaritan Medical Center
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33401
Country
United States
Facility Name
University of Chicago Cancer Research Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637-1470
Country
United States
Facility Name
Louis A. Weiss Memorial Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60640
Country
United States
Facility Name
West Suburban Center for Cancer Care
City
River Forest
State/Province
Illinois
ZIP/Postal Code
60305
Country
United States
Facility Name
Saint Anthony Medical Center
City
Rockford
State/Province
Illinois
ZIP/Postal Code
61108
Country
United States
Facility Name
Fort Wayne Medical Oncology and Hematology, Incorporated
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46885-5099
Country
United States
Facility Name
Baptist Hospital East - Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40207
Country
United States
Facility Name
Veterans Affairs Medical Center - Baltimore
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Massachusetts General Hospital Cancer Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Beth Israel Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Lakeland Medical Center - St. Joseph
City
Saint Joseph
State/Province
Michigan
ZIP/Postal Code
49085
Country
United States
Facility Name
Ellis Fischel Cancer Center - Columbia
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65203
Country
United States
Facility Name
Barnes-Jewish Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198-7680
Country
United States
Facility Name
Veterans Affairs Medical Center - Las Vegas
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Facility Name
Cooper University Hospital
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08103
Country
United States
Facility Name
Elmhurst Hospital Center
City
Elmhurst
State/Province
New York
ZIP/Postal Code
11373
Country
United States
Facility Name
Queens Cancer Center of Queens Hospital
City
Jamaica
State/Province
New York
ZIP/Postal Code
11432
Country
United States
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
State University of New York - Upstate Medical University
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Veterans Affairs Medical Center - Syracuse
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
City
Syracuse
State/Province
New York
ZIP/Postal Code
13217
Country
United States
Facility Name
Veterans Affairs Medical Center - Asheville
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28805
Country
United States
Facility Name
NorthEast Oncology Associates
City
Concord
State/Province
North Carolina
ZIP/Postal Code
28025
Country
United States
Facility Name
Veterans Affairs Medical Center - Durham
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
Cape Fear Valley Health System
City
Fayetteville
State/Province
North Carolina
ZIP/Postal Code
28302-2000
Country
United States
Facility Name
Lenoir Memorial Hospital Cancer Center
City
Kinston
State/Province
North Carolina
ZIP/Postal Code
28503-1678
Country
United States
Facility Name
FirstHealth Moore Regional Hospital
City
Pinehurst
State/Province
North Carolina
ZIP/Postal Code
28374
Country
United States
Facility Name
New Hanover Regional Medical Center
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28402-9025
Country
United States
Facility Name
Veterans Affairs Medical Center - Fargo
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58102
Country
United States
Facility Name
Veterans Affairs Medical Center - Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75216
Country
United States
Facility Name
Martha Jefferson Hospital
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22901
Country
United States
Facility Name
Virginia Oncology Associates - Norfolk
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Oncology and Hematology Associates of Southwest Virginia, Inc.
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24014
Country
United States
Facility Name
St. Mary's Medical Center
City
Huntington
State/Province
West Virginia
ZIP/Postal Code
25701
Country
United States
Facility Name
Ministry Medical Group - Northern Region
City
Rhinelander
State/Province
Wisconsin
ZIP/Postal Code
54501
Country
United States
Facility Name
University of Puerto Rico School of Medicine Medical Sciences Campus
City
San Juan
ZIP/Postal Code
00936-5067
Country
Puerto Rico

12. IPD Sharing Statement

Learn more about this trial

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

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