NCT06225011RecruitingPhase 1
Fluoxetine for the Modification of Colorectal Tumor Immune Cells Before Surgery in Patients With Colorectal Cancer
Repurposing Drugs as Immunotherapeutic Agents: Changes in Colorectal Tumor Immune Cells After Targeting Serotonin
Source: ClinicalTrials.gov · Last updated 20 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 10 (estimated)
- First submitted
- 4 Jan 2024
- Start date
- 20 Mar 2025
- Primary completion date
- 1 Jul 2027
- Lead sponsor
- Jonsson Comprehensive Cancer Center
- Diseases
- Colorectal cancer
- NCT number
- NCT06225011
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 10
- From 20 Mar 2025 to the primary completion date, 1 Jul 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Individuals who have received neoadjuvant chemotherapy prior to the planned colon cancer resection
- Individuals using other SSRIs, serotonin and norepinephrine reuptake inhibitors (SNRIs), monoamine oxidase inhibitors (MAOIs), lithium or other antidepressants at time of initial biopsy
Other illness
- 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
- 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)
Lab values
- Individuals with absolute or relative contraindications to fluoxetine
- Baseline prolonged QTc
- Concurrently taking tamoxifen, pimozide, or thioridazine
Other
- A diagnosis of metastatic colorectal adenocarcinoma
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UCLA / Jonsson Comprehensive Cancer Center Coordinator of this site? Confirm its status | Los Angeles | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.