Fluoxetine for Colorectal Cancer

Recruiting in Los Angeles (>99 mi)

Overseen By Jasmine Mitchell, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Jonsson Comprehensive Cancer Center

Must be taking: Fluoxetine

Must not be taking: Tamoxifen, Pimozide, Thioridazine, others

Disqualifiers: Metastatic cancer, Neoadjuvant chemotherapy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 10 days

10 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

If you are currently taking tamoxifen, pimozide, thioridazine, or any antidepressants like SSRIs, SNRIs, MAOIs, or lithium, you will need to stop these medications to participate in the trial.

Is fluoxetine safe for humans?

Fluoxetine (Prozac) has been widely used as an antidepressant and is generally considered safe for humans. Studies in animals have shown no evidence of it causing cancer, and it is not known to promote tumor growth. However, it can have side effects like decreased weight gain and changes in liver cells in animals. ^{1 2 3 4 5}

How does fluoxetine differ from other drugs for colorectal cancer?

Fluoxetine is traditionally used as an antidepressant and its use in colorectal cancer is novel, as it is not a standard treatment for this condition. This trial explores its potential new application, which is different from the typical chemotherapy drugs like 5-fluorouracil and irinotecan that are commonly used for colorectal cancer. ^{6 7 8 9 10}

Research Team

Randolph Hecht, MD

Principal Investigator

UCLA / Jonsson Comprehensive Cancer Center

Eligibility Criteria

This trial is for individuals with colorectal cancer who are scheduled for surgery. The study is exploring if fluoxetine, a medication typically used for depression and anxiety, can alter immune cells in the tumor before surgery.

Inclusion Criteria

Platelets ≥ 100x10^9/L

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

Aspartate aminotransferase (AST)(serum glutamic-oxaloacetic transaminase [SGOT]) / alanine aminotransferase (ALT)(serum glutamate pyruvate transaminase [SGPT]) ≤ 2.5 x ULN

Exclusion Criteria

I have been diagnosed with advanced colorectal cancer.

I have had chemotherapy before my planned colon cancer surgery.

I have no active cancer other than skin cancer (not melanoma) in the past 5 years.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive fluoxetine orally once daily for 10 days prior to surgery

10 days

Follow-up

Participants are monitored for changes in immune cell composition and activity after treatment

up to 1 year

Treatment Details

Interventions

• Fluoxetine

Trial Overview The trial is testing fluoxetine's effect on modifying tumor immune cells in colorectal cancer patients. It aims to see if this common antidepressant can change the immune environment of the tumor and potentially hinder cancer growth and spread.

Participant Groups

Group I: Treatment (fluoxetine) Experimental Treatment 1 Intervention

Patients receive fluoxetine PO once QD for 10 days prior to surgery.

Who Is Running the Clinical Trial?

Jonsson Comprehensive Cancer Center

Lead Sponsor

Trials

373

Recruited

35,200+

Findings from Research

Approximately 50% of colorectal cancer patients develop metastatic disease, but long-term disease-free survival can be achieved in 25% to 40% of selected patients who undergo resection of liver or lung metastases.

New treatments like irinotecan and oxaliplatin, along with novel therapies such as targeted inhibitors and local interventions, have improved survival and quality of life for colorectal cancer patients, moving beyond the traditional use of 5-fluorouracil.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Metastatic colorectal cancer. Kindler, HL., Shulman, KL.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Pros and cons of fluoxetine for the depressed cancer patient. [2013]

2. England pubmed.ncbi.nlm.nih.gov

Use of antidepressants and risk of colorectal cancer: a nested case-control study. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Antidepressant use and colorectal cancer risk. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Carcinogenicity studies of fluoxetine hydrochloride in rats and mice. [2013]

5. England pubmed.ncbi.nlm.nih.gov

Fluoxetine increases extracellular levels of 3-methoxy-4-hydroxyphenylglycol in cultured COLO320 DM cells. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Metastatic colorectal cancer. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

A comprehensive review of 5-fluorouracil and leucovorin in patients with metastatic colorectal carcinoma. [2019]

8. England pubmed.ncbi.nlm.nih.gov

Oral drugs in the treatment of metastatic colorectal cancer. [2023]

9. England pubmed.ncbi.nlm.nih.gov

An overview of adjuvant therapy for colorectal cancer. [2022]

10. Switzerland pubmed.ncbi.nlm.nih.gov

[Current aspects of adjuvant and palliative chemotherapy in colorectal carcinoma]. [2008]