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

a study on Colorectal Cancer Colorectal Tumor

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Los Angeles, California
Dates
study started
completion around
Principal Investigator
by Randolph Hecht, MD

Description

Summary

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.

Official Title

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

Details

PRIMARY OBJECTIVE:

  1. 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.

Keywords

Colorectal Adenocarcinoma, Colorectal Neoplasms, Fluoxetine

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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) ≥ 1.5x109/L
  • Platelets ≥ 100x109/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

You CAN'T join if...

  • 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)

Location

  • UCLA / Jonsson Comprehensive Cancer Center
    Los Angeles California 90095 United States

Lead Scientist at UCLA

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
Jonsson Comprehensive Cancer Center
Links
Sign up for this study
ID
NCT06225011
Phase
Phase 1 research study
Study Type
Interventional
Participants
Expecting 10 study participants
Last Updated
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