Actively Recruiting
Fluoxetine for the Modification of Colorectal Tumor Immune Cells Before Surgery in Patients With Colorectal Cancer
Led by Jonsson Comprehensive Cancer Center · Updated on 2026-05-11
10
Participants Needed
1
Research Sites
119 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Fluoxetine for the Modification of Colorectal Tumor Immune Cells Before Surgery in Patients With Colorectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female 18 years of age or older at visit 1
- Previously untreated cytologically or histologically confirmed colorectal adenocarcinoma that will not need neoadjuvant therapy
- Written informed consent obtained and ability to comply with study requirements
- WHO Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Absolute neutrophil count (ANC) of at least 1.5 x 10^9/L
- Platelet count of at least 100 x 10^9/L
- Hemoglobin level of at least 9 g/dL
- Serum creatinine at or below 1.5 times the upper limit of normal (ULN)
- Creatinine clearance of at least 40 mL/min calculated by Modified Cockcroft-Gault formula
- Serum total bilirubin at or below 1.5 times ULN
- AST and ALT levels at or below 2.5 times ULN
- Baseline corrected QT interval within normal limits (350-450 ms for men, 360-460 ms for women)
You will not qualify if you...
- Any condition or abnormality that may compromise participant safety or data quality
- Diagnosis of metastatic colorectal adenocarcinoma
- Previous neoadjuvant chemotherapy before planned colon cancer surgery
- Contraindications to fluoxetine such as prolonged QTc or concurrent use of tamoxifen, pimozide, or thioridazine
- Current use of SSRIs, SNRIs, MAOIs, lithium, or other antidepressants at initial biopsy
- Active second primary cancer or history of malignancy within 5 years, except non-melanoma skin cancers
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, United States, 90095
Actively Recruiting
Research Team
J
Jasmine Mitchell, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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