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

Fluoxetine in Stage IIIB/IV Non-Small Cell Lung Cancer (NSCLC): A Phase II Pilot Study to Improve Quality of Life During Chemotherapy

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.

Study Overview

• Status: Completed
• Conditions: Depression; Fatigue; Lung Cancer; Anxiety Disorder
• Intervention / Treatment: Drug: cisplatin; Drug: fluoxetine; Drug: gemcitabine hydrochloride

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 Type: Interventional
• Enrollment (Actual): 21
• Phase: Phase 2

Contacts and Locations

Study Locations

• Puerto Rico
  • San Juan, Puerto Rico, 00936-5067
    • University of Puerto Rico School of Medicine Medical Sciences Campus
• United States
  • Alabama
    • Anniston, Alabama, United States, 36207
      • Northeast Alabama Regional Medical Center
  • California
    • San Diego, California, United States, 92161
      • Veterans Affairs Medical Center - San Diego
  • District of Columbia
    • Washington, District of Columbia, United States, 20422
      • Veterans Affairs Medical Center - Washington, DC
  • Florida
    • Fort Lauderdale, Florida, United States, 33316
      • Broward General Medical Center
    • Hollywood, Florida, United States, 33021
      • Memorial Regional Hospital Comprehensive Cancer Center
    • Orlando, Florida, United States, 32804
      • Florida Hospital Cancer Institute
    • West Palm Beach, Florida, United States, 33401
      • Helen and Harry Gray Cancer Institute at Good Samaritan Medical Center
  • Illinois
    • Chicago, Illinois, United States, 60637-1470
      • University of Chicago Cancer Research Center
    • Chicago, Illinois, United States, 60640
      • Louis A. Weiss Memorial Hospital
    • River Forest, Illinois, United States, 60305
      • West Suburban Center for Cancer Care
    • Rockford, Illinois, United States, 61108
      • Saint Anthony Medical Center
  • Indiana
    • Fort Wayne, Indiana, United States, 46885-5099
      • Fort Wayne Medical Oncology and Hematology, Incorporated
  • Kentucky
    • Louisville, Kentucky, United States, 40207
      • Baptist Hospital East - Louisville
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • Veterans Affairs Medical Center - Baltimore
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital Cancer Center
    • Boston, Massachusetts, United States, 02115
      • Beth Israel Medical Center
  • Michigan
    • Saint Joseph, Michigan, United States, 49085
      • Lakeland Medical Center - St. Joseph
  • Missouri
    • Columbia, Missouri, United States, 65203
      • Ellis Fischel Cancer Center - Columbia
    • Saint Louis, Missouri, United States, 63110
      • Barnes-Jewish Hospital
  • Nebraska
    • Omaha, Nebraska, United States, 68198-7680
      • University of Nebraska Medical Center
  • Nevada
    • Las Vegas, Nevada, United States, 89106
      • Veterans Affairs Medical Center - Las Vegas
  • New Jersey
    • Camden, New Jersey, United States, 08103
      • Cooper University Hospital
  • New York
    • Elmhurst, New York, United States, 11373
      • Elmhurst Hospital Center
    • Jamaica, New York, United States, 11432
      • Queens Cancer Center of Queens Hospital
    • New York, New York, United States, 10021
      • Memorial Sloan-Kettering Cancer Center
    • Syracuse, New York, United States, 13210
      • State University of New York - Upstate Medical University
    • Syracuse, New York, United States, 13210
      • Veterans Affairs Medical Center - Syracuse
    • Syracuse, New York, United States, 13217
      • CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
  • North Carolina
    • Asheville, North Carolina, United States, 28805
      • Veterans Affairs Medical Center - Asheville
    • Concord, North Carolina, United States, 28025
      • NorthEast Oncology Associates
    • Durham, North Carolina, United States, 27705
      • Veterans Affairs Medical Center - Durham
    • Fayetteville, North Carolina, United States, 28302-2000
      • Cape Fear Valley Health System
    • Kinston, North Carolina, United States, 28503-1678
      • Lenoir Memorial Hospital Cancer Center
    • Pinehurst, North Carolina, United States, 28374
      • Firsthealth Moore Regional Hospital
    • Wilmington, North Carolina, United States, 28402-9025
      • New Hanover Regional Medical Center
  • North Dakota
    • Fargo, North Dakota, United States, 58102
      • Veterans Affairs Medical Center - Fargo
  • Texas
    • Dallas, Texas, United States, 75216
      • Veterans Affairs Medical Center - Dallas
  • Virginia
    • Charlottesville, Virginia, United States, 22901
      • Martha Jefferson Hospital
    • Norfolk, Virginia, United States, 23502
      • Virginia Oncology Associates - Norfolk
    • Roanoke, Virginia, United States, 24014
      • Oncology and Hematology Associates of Southwest Virginia, Inc.
  • West Virginia
    • Huntington, West Virginia, United States, 25701
      • St. Mary's Medical Center
  • Wisconsin
    • Rhinelander, Wisconsin, United States, 54501
      • Ministry Medical Group - Northern Region

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Eligibility Criteria:

1. 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).

2. 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.

3. 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

4. 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.
5. 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.
6. CTC Performance Status 0-1.
7. Non-pregnant and non-nursing because of significant risk to the fetus/infant.

8. 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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.

Drug: cisplatin; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Alliance for Clinical Trials in Oncology
• Collaborators: National Cancer Institute (NCI)
• Investigators: Study Chair: Donna Greenberg, MD, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start: August 1, 2001
• Primary Completion (ACTUAL): September 1, 2003
• Study Completion (ACTUAL): September 1, 2003

Study Registration Dates

• First Submitted: June 2, 2000
• First Submitted That Met QC Criteria: January 26, 2003
• First Posted (ESTIMATE): January 27, 2003

Study Record Updates

• Last Update Posted (ESTIMATE): July 4, 2016
• Last Update Submitted That Met QC Criteria: July 1, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: recurrent non-small cell lung cancer; stage IIIA non-small cell lung cancer; stage IIIB non-small cell lung cancer; stage IV non-small cell lung cancer; fatigue; depression; squamous cell lung cancer; large cell lung cancer; adenocarcinoma of the lung; stage I non-small cell lung cancer; stage II non-small cell lung cancer; anxiety disorder; adenosquamous cell lung cancer
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Depression; Fatigue; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Anxiety Disorders; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Cytochrome P-450 Enzyme Inhibitors; Antidepressive Agents, Second-Generation; Cytochrome P-450 CYP2D6 Inhibitors; Gemcitabine; Cisplatin; Fluoxetine
• Other Study ID Numbers: CALGB-119802; U10CA031946 (U.S. NIH Grant/Contract); CLB-119802; CDR0000067871 (REGISTRY: NCI Physician Data Query)