CompletedPhase 2NCT00005850

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

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.

Checked against the public recordLast updated Jul 4, 2016 · Source: ClinicalTrials.gov

StatusCompleted
PhasePhase 2
U.S. locations43
SponsorAlliance for Clinical Trials in Oncology
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2
Sponsor
Alliance for Clinical Trials in Oncology
Interventions being studied
Drug: cisplatin; Drug: fluoxetine; Drug: gemcitabine hydrochloride
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Northeast Alabama Regional Medical CenterAnniston, Alabama
  • Veterans Affairs Medical Center - San DiegoSan Diego, California
  • Veterans Affairs Medical Center - Washington, DCWashington D.C., District of Columbia
  • Broward General Medical CenterFort Lauderdale, Florida
  • Memorial Regional Hospital Comprehensive Cancer CenterHollywood, Florida
  • Florida Hospital Cancer InstituteOrlando, Florida
  • Helen and Harry Gray Cancer Institute at Good Samaritan Medical CenterWest Palm Beach, Florida
  • University of Chicago Cancer Research CenterChicago, Illinois
  • Louis A. Weiss Memorial HospitalChicago, Illinois
  • West Suburban Center for Cancer CareRiver Forest, Illinois
  • Saint Anthony Medical CenterRockford, Illinois
  • Fort Wayne Medical Oncology and Hematology, IncorporatedFort Wayne, Indiana

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jul 4, 2016. Always confirm current availability with the study team.

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