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

Study 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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedcisplatin and fluoxetine

Plus 1 other study approaches.

Who it may be forNon-small cell lung cancer (NSCLC) · Recurrent or relapsed

These are broad labels—not an eligibility decision.

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

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 2

Interventional

Where is it offered?43 U.S. locations

Locations may change over time.

Who runs it?Alliance for Clinical Trials in Oncology

Study sponsor

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

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How this study is categorized

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

Cancer type

Non-small cell lung cancer (NSCLC)→

Disease setting

Recurrent or relapsed→

Treatment approach

Chemotherapy→

Study topics

Survivorship and quality of life→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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

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

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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