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Recruiting NCT06225011

Fluoxetine for the Modification of Colorectal Tumor Immune Cells Before Surgery in Patients With Colorectal Cancer

Phase I Interventional Colorectal Adenocarcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Fluoxetine.
Who it may be relevant to
Registry conditions: Colorectal Adenocarcinoma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Repurposing Drugs as Immunotherapeutic Agents: Changes in Colorectal Tumor Immune Cells After Targeting Serotonin

Overview

This phase I trial tests whether fluoxetine (prozac) works to modify the tumor immune cells before surgery in patients with colorectal cancer. Fluoxetine is a commonly used selective serotonin reuptake inhibitor (SSRI) prescribed for major depressive disorder and generalized anxiety. Giving fluoxetine may modify the immune cell composition in the tumor and its microenvironment and may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread in patients with colorectal cancer.

Detailed description

PRIMARY OBJECTIVE:

I. To evaluate alterations in tumor immune cell composition and activity under SSRI treatment.

OUTLINE:

Patients receive fluoxetine orally (PO) once daily (QD) for 10 days prior to surgery.

Interventions

  • Drug Fluoxetine
    Receive PO

Primary outcome measures

  • Immune cell composition and microenvironment [Time frame: within a year of surgery]

Eligibility criteria

Inclusion criteria

  • Male or female ≥ 18 years of age at visit 1
  • Previously untreated cytologically or histologically confirmed colorectal adenocarcinoma that will not need neoadjuvant therapy
  • Written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study
  • World Health Organization (WHO) Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Absolute neutrophil count (ANC) ≥ 1.5x10\^9/L
  • Platelets ≥ 100x10\^9/L
  • Hemoglobin ≥ 9 g/dL
  • Serum creatinine (sCr) ≤ 1.5 x upper limit of normal (ULN)
  • Creatinine clearance (Ccr) ≥ 40 mL/min (as calculated by Modified Cockcroft-Gault formula)
  • Serum total bilirubin ≤ 1.5 x ULN
  • Aspartate aminotransferase (AST)(serum glutamic-oxaloacetic transaminase \[SGOT\]) / alanine aminotransferase (ALT)(serum glutamate pyruvate transaminase \[SGPT\]) ≤ 2.5 x ULN
  • Baseline corrected QT (QTc) within normal limits per the Bazett formula. Any electrocardiogram (EKG) done prior to consent is acceptable for baseline QTc monitoring.
  • Normal QTc ranges from 350-450 ms for adult men and from 360-460 ms for adult women

Exclusion criteria

  • Presence of a condition or abnormality that in the opinion of the investigator would compromise the safety of the participant or the quality of the data
  • A diagnosis of metastatic colorectal adenocarcinoma
  • Individuals who have received neoadjuvant chemotherapy prior to the planned colon cancer resection
  • Individuals with absolute or relative contraindications to fluoxetine
  • Baseline prolonged QTc
  • Concurrently taking tamoxifen, pimozide, or thioridazine
  • Individuals using other SSRIs, serotonin and norepinephrine reuptake inhibitors (SNRIs), monoamine oxidase inhibitors (MAOIs), lithium or other antidepressants at time of initial biopsy
  • Currently active second primary malignancy or history of malignancy less than 5 years prior to the time of study eligibility (Patients with history of skin cancers excluding melanoma will be eligible for participation)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • UCLA / Jonsson Comprehensive Cancer Center — Los Angeles

Identifiers

NCT: NCT06225011 · 23-001744 · NCI-2023-09939

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗