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

Information source: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Anxiety Disorder; Depression; Fatigue; Lung Cancer

Intervention: cisplatin (Drug); fluoxetine (Drug); gemcitabine hydrochloride (Drug)

Phase: Phase 2

Status: Terminated

Sponsored by: Alliance for Clinical Trials in Oncology

Official(s) and/or principal investigator(s):
Donna Greenberg, MD, Study Chair, Affiliation: Massachusetts General Hospital

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.

Clinical Details

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

Primary outcome: Quality of Life (QOL)

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.

Eligibility

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

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

Northeast Alabama Regional Medical Center, Anniston, Alabama 36207, United States

Veterans Affairs Medical Center - San Diego, San Diego, California 92161, United States

Veterans Affairs Medical Center - Washington, DC, Washington, District of Columbia 20422, United States

Broward General Medical Center, Fort Lauderdale, Florida 33316, United States

Memorial Regional Hospital Comprehensive Cancer Center, Hollywood, Florida 33021, United States

Florida Hospital Cancer Institute, Orlando, Florida 32804, United States

Helen and Harry Gray Cancer Institute at Good Samaritan Medical Center, West Palm Beach, Florida 33401, United States

Louis A. Weiss Memorial Hospital, Chicago, Illinois 60640, United States

University of Chicago Cancer Research Center, Chicago, Illinois 60637-1470, United States

West Suburban Center for Cancer Care, River Forest, Illinois 60305, United States

Saint Anthony Medical Center, Rockford, Illinois 61108, United States

Fort Wayne Medical Oncology and Hematology, Incorporated, Fort Wayne, Indiana 46885-5099, United States

Baptist Hospital East - Louisville, Louisville, Kentucky 40207, United States

Veterans Affairs Medical Center - Baltimore, Baltimore, Maryland 21201, United States

Beth Israel Medical Center, Boston, Massachusetts 02115, United States

Massachusetts General Hospital Cancer Center, Boston, Massachusetts 02114, United States

Lakeland Medical Center - St. Joseph, Saint Joseph, Michigan 49085, United States

Ellis Fischel Cancer Center - Columbia, Columbia, Missouri 65203, United States

Barnes-Jewish Hospital, Saint Louis, Missouri 63110, United States

University of Nebraska Medical Center, Omaha, Nebraska 68198-7680, United States

Veterans Affairs Medical Center - Las Vegas, Las Vegas, Nevada 89106, United States

Cooper University Hospital, Camden, New Jersey 08103, United States

Elmhurst Hospital Center, Elmhurst, New York 11373, United States

Queens Cancer Center of Queens Hospital, Jamaica, New York 11432, United States

Memorial Sloan-Kettering Cancer Center, New York, New York 10021, United States

CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C., Syracuse, New York 13217, United States

State University of New York - Upstate Medical University, Syracuse, New York 13210, United States

Veterans Affairs Medical Center - Syracuse, Syracuse, New York 13210, United States

Veterans Affairs Medical Center - Asheville, Asheville, North Carolina 28805, United States

NorthEast Oncology Associates, Concord, North Carolina 28025, United States

Veterans Affairs Medical Center - Durham, Durham, North Carolina 27705, United States

Cape Fear Valley Health System, Fayetteville, North Carolina 28302-2000, United States

Lenoir Memorial Hospital Cancer Center, Kinston, North Carolina 28503-1678, United States

FirstHealth Moore Regional Hospital, Pinehurst, North Carolina 28374, United States

New Hanover Regional Medical Center, Wilmington, North Carolina 28402-9025, United States

Veterans Affairs Medical Center - Fargo, Fargo, North Dakota 58102, United States

Veterans Affairs Medical Center - Dallas, Dallas, Texas 75216, United States

Martha Jefferson Hospital, Charlottesville, Virginia 22901, United States

Virginia Oncology Associates - Norfolk, Norfolk, Virginia 23502, United States

Oncology and Hematology Associates of Southwest Virginia, Inc., Roanoke, Virginia 24014, United States

St. Mary's Medical Center, Huntington, West Virginia 25701, United States

Ministry Medical Group - Northern Region, Rhinelander, Wisconsin 54501, United States

Additional Information

Starting date: August 2001
Last updated: September 18, 2013

Page last updated: August 23, 2015

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