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

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT00005850
First received: June 2, 2000
Last updated: July 1, 2016
Last verified: July 2016
  Purpose
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.

Condition Intervention Phase
Anxiety Disorder
Depression
Fatigue
Lung Cancer
Drug: cisplatin
Drug: fluoxetine
Drug: gemcitabine hydrochloride
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Alliance for Clinical Trials in Oncology:

Primary Outcome Measures:
  • Change in the MHI-17 global psychological distress subscale [ Time Frame: Up to 8 weeks ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: Up to 2 years post-treatment ] [ Designated as safety issue: No ]
  • Failure-free survival [ Time Frame: Up to 2 years post-treatment ] [ Designated as safety issue: No ]

Enrollment: 21
Study Start Date: August 2001
Study Completion Date: September 2003
Primary Completion Date: September 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00005850

  Show 43 Study Locations
Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Investigators
Study Chair: Donna Greenberg, MD Massachusetts General Hospital
  More Information

Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00005850     History of Changes
Other Study ID Numbers: CALGB-119802  U10CA031946  CLB-119802  CDR0000067871 
Study First Received: June 2, 2000
Last Updated: July 1, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by Alliance for Clinical Trials in Oncology:
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

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Depression
Fatigue
Anxiety Disorders
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Behavioral Symptoms
Signs and Symptoms
Mental Disorders
Gemcitabine
Cisplatin
Fluoxetine
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Serotonin Uptake Inhibitors

ClinicalTrials.gov processed this record on December 08, 2016