Fluoxetine treatment to modify immune cells in colorectal cancer patients before surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase I trial investigates the effects of fluoxetine, a selective serotonin reuptake inhibitor, on tumor immune cell composition in patients with colorectal adenocarcinoma prior to surgery. Participants will take fluoxetine orally once daily for 10 days, aiming to alter the immune environment of the tumor and potentially inhibit tumor growth and spread. The primary objective is to evaluate changes in immune cell activity and composition resulting from the treatment.

Why it matters

Who can join: the full rules

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)

Where it's running

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

Study contacts

• Principal investigator: Jasmine Mitchell, MD — UCLA / Jonsson Comprehensive Cancer Center
• Study coordinator: Jasmine Mitchell, MD
• Email: jlmitchell@mednet.ucla.edu
• Phone: 310-825-0712

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.