Anxiety DisorderPhase 2NCT00005850

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

A Phase 2 study testing cisplatin, fluoxetine and gemcitabine hydrochloride in people with Anxiety Disorder and Depression, run by Alliance for Clinical Trials in Oncology at 43 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

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. Read more about this study

Who is it for?: Any age
Conditions the study is for: Anxiety Disorder, Depression, Fatigue
What is being tested?: cisplatin, fluoxetine and gemcitabine hydrochloride
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 21 participants
Where: 43 sitesin 2 countries
Study dates: Aug 2001to Sep 2003
Phase: Phase 2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

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

Trial locations and contacts

43 sites in 2 countries.

Country

City, postcode or hospital

43 sites in 2 countries

United States42 sites

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

Other trials in United States

Puerto Rico1 site

University of Puerto Rico School of Medicine Medical Sciences Campus
San Juan, 00936-5067

Other trials in Puerto Rico

About this study

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

Read the 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.

Conditions: Anxiety Disorder, Depression, Fatigue, Lung Cancer
Being tested: cisplatin, fluoxetine, gemcitabine hydrochloride
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
Medical subject headings: Anxiety Disorders, Depression, Fatigue, Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Adenocarcinoma of Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

cisplatinDrug
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.
fluoxetineDrug
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 hydrochlorideDrug
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.

Study groups in NCT00005850
Study group	Role	What they receive
gemcitabine + cisplatin + fluoxetine	Experimental	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. Receives: Drug: cisplatin; Drug: fluoxetine; Drug: gemcitabine hydrochloride

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2001Sep 2003

First posted27 Jan 2003 (estimated)
Study startAug 2001
Primary completionSep 2003
Study completionSep 2003

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Anxiety DisorderStudies of the same condition, open and under way.
More trials run by Alliance for Clinical Trials in OncologyThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 21 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00005850
Sponsor's protocol ID: CALGB-119802
Other IDs: U10CA031946, CLB-119802, CDR0000067871
Status last verified: Jul 2016
First submitted: 2 Jun 2000
Last updated: 4 Jul 2016
Results posted: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence

All Anxiety Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT00005850
Acronym / sponsor ID: CALGB-119802
Conditions: 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
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 21 participants (actual)
Lead sponsor: Alliance for Clinical Trials in OncologyUniversity, hospital or other
Collaborators: National Cancer Institute (NCI)
Study start: Aug 2001
Primary completion: Sep 2003 (actual)
Study completion: Sep 2003 (actual)
First posted: 27 Jan 2003 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
gemcitabine + cisplatin + fluoxetine	Experimental	Drug: cisplatin, Drug: fluoxetine, Drug: gemcitabine hydrochloridePatients 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.

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
cisplatin80 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	gemcitabine + cisplatin + fluoxetine
fluoxetine10 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 + cisplatin + fluoxetine
gemcitabine hydrochloride1000 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.	Drug	gemcitabine + cisplatin + fluoxetine

Primary outcome

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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Jul 2016.

Related trials for Anxiety Disorder

Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Donna Greenberg, MD study chair

Massachusetts General Hospital

43 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing cisplatin, fluoxetine and gemcitabine hydrochloride in people with Anxiety Disorder and Depression, run by Alliance for Clinical Trials in Oncology at 43 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 43 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in the MHI-17 global psychological distress subscale (time frame: Up to 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00005850.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jul 2016.