NCT06225011 Fluoxetine for the Modification of Colorectal Tumor Immune Cells Before Surgery in Patients With Colorectal Cancer
| NCT ID | NCT06225011 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Jonsson Comprehensive Cancer Center |
| Condition | Colorectal Adenocarcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2025-03-20 |
| Primary Completion | 2027-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 10 participants in total. It began in 2025-03-20 with a primary completion date of 2027-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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)
Contact & Investigator
Jasmine Mitchell, MD
PRINCIPAL INVESTIGATOR
UCLA / Jonsson Comprehensive Cancer Center
Frequently Asked Questions
Who can join the NCT06225011 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Colorectal Adenocarcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06225011 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06225011 currently recruiting?
Yes, NCT06225011 is actively recruiting participants. Contact the research team at jlmitchell@mednet.ucla.edu for enrollment information.
Where is the NCT06225011 trial being conducted?
This trial is being conducted at Los Angeles, United States.
Who is sponsoring the NCT06225011 clinical trial?
NCT06225011 is sponsored by Jonsson Comprehensive Cancer Center. The principal investigator is Jasmine Mitchell, MD at UCLA / Jonsson Comprehensive Cancer Center. The trial plans to enroll 10 participants.