Combination Chemotherapy Plus Fluoxetine in Treating Patients With Advanced or Recurrent Non-Small Cell Lung Cancer
Anxiety Disorder, Depression, Fatigue
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
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
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.