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Trial Title:
Fluoxetine for the Modification of Colorectal Tumor Immune Cells Before Surgery in Patients With Colorectal Cancer
NCT ID:
NCT06225011
Condition:
Colorectal Adenocarcinoma
Conditions: Official terms:
Colorectal Neoplasms
Fluoxetine
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Fluoxetine
Description:
Receive PO
Arm group label:
Treatment (fluoxetine)
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.
Detailed description:
PRIMARY OBJECTIVE:
I. 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.
Criteria for 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)
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
UCLA / Jonsson Comprehensive Cancer Center
Address:
City:
Los Angeles
Zip:
90095
Country:
United States
Contact:
Last name:
Jasmine Mitchell, MD
Phone:
310-825-0712
Email:
jlmitchell@mednet.ucla.edu
Investigator:
Last name:
Randolph Hecht, MD
Email:
Principal Investigator
Start date:
December 1, 2024
Completion date:
December 1, 2026
Lead sponsor:
Agency:
Jonsson Comprehensive Cancer Center
Agency class:
Other
Source:
Jonsson Comprehensive Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06225011
