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

Depression Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00005850
• Other study ID #: CALGB-119802
• Secondary ID: U10CA031946CLB-1
• Status: Completed
• Phase: Phase 2
• First received: June 2, 2000
• Last updated: July 1, 2016
• Start date: August 2001
• Est. completion date: September 2003

Study information

• Verified date: July 2016
• Source: Alliance for Clinical Trials in Oncology
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: September 2003
• Est. primary completion date: September 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anxiety Disorder
• Anxiety Disorders
• Carcinoma, Non-Small-Cell Lung
• Depression
• Fatigue
• Lung Cancer
• Lung Neoplasms

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
Puerto Rico	University of Puerto Rico School of Medicine Medical Sciences Campus	San Juan
United States	Northeast Alabama Regional Medical Center	Anniston	Alabama
United States	Veterans Affairs Medical Center - Asheville	Asheville	North Carolina
United States	Veterans Affairs Medical Center - Baltimore	Baltimore	Maryland
United States	Beth Israel Medical Center	Boston	Massachusetts
United States	Massachusetts General Hospital Cancer Center	Boston	Massachusetts
United States	Cooper University Hospital	Camden	New Jersey
United States	Martha Jefferson Hospital	Charlottesville	Virginia
United States	Louis A. Weiss Memorial Hospital	Chicago	Illinois
United States	University of Chicago Cancer Research Center	Chicago	Illinois
United States	Ellis Fischel Cancer Center - Columbia	Columbia	Missouri
United States	NorthEast Oncology Associates	Concord	North Carolina
United States	Veterans Affairs Medical Center - Dallas	Dallas	Texas
United States	Veterans Affairs Medical Center - Durham	Durham	North Carolina
United States	Elmhurst Hospital Center	Elmhurst	New York
United States	Veterans Affairs Medical Center - Fargo	Fargo	North Dakota
United States	Cape Fear Valley Health System	Fayetteville	North Carolina
United States	Broward General Medical Center	Fort Lauderdale	Florida
United States	Fort Wayne Medical Oncology and Hematology, Incorporated	Fort Wayne	Indiana
United States	Memorial Regional Hospital Comprehensive Cancer Center	Hollywood	Florida
United States	St. Mary's Medical Center	Huntington	West Virginia
United States	Queens Cancer Center of Queens Hospital	Jamaica	New York
United States	Lenoir Memorial Hospital Cancer Center	Kinston	North Carolina
United States	Veterans Affairs Medical Center - Las Vegas	Las Vegas	Nevada
United States	Baptist Hospital East - Louisville	Louisville	Kentucky
United States	Memorial Sloan-Kettering Cancer Center	New York	New York
United States	Virginia Oncology Associates - Norfolk	Norfolk	Virginia
United States	University of Nebraska Medical Center	Omaha	Nebraska
United States	Florida Hospital Cancer Institute	Orlando	Florida
United States	FirstHealth Moore Regional Hospital	Pinehurst	North Carolina
United States	Ministry Medical Group - Northern Region	Rhinelander	Wisconsin
United States	West Suburban Center for Cancer Care	River Forest	Illinois
United States	Oncology and Hematology Associates of Southwest Virginia, Inc.	Roanoke	Virginia
United States	Saint Anthony Medical Center	Rockford	Illinois
United States	Lakeland Medical Center - St. Joseph	Saint Joseph	Michigan
United States	Barnes-Jewish Hospital	Saint Louis	Missouri
United States	Veterans Affairs Medical Center - San Diego	San Diego	California
United States	CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.	Syracuse	New York
United States	State University of New York - Upstate Medical University	Syracuse	New York
United States	Veterans Affairs Medical Center - Syracuse	Syracuse	New York
United States	Veterans Affairs Medical Center - Washington, DC	Washington	District of Columbia
United States	Helen and Harry Gray Cancer Institute at Good Samaritan Medical Center	West Palm Beach	Florida
United States	New Hanover Regional Medical Center	Wilmington	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Alliance for Clinical Trials in Oncology	National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the MHI-17 global psychological distress subscale		Up to 8 weeks	No
Primary	Overall survival		Up to 2 years post-treatment	No
Primary	Failure-free survival		Up to 2 years post-treatment	No