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RecruitingPhase 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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This early-stage study tests whether fluoxetine (Prozac) changes immune cells in and around colon or rectal tumors before surgery. It is for adults with untreated colon or rectal cancer who do not need cancer treatment before surgery.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 18 or older at the first visit.
  • Have untreated colorectal adenocarcinoma, a type of colon or rectal cancer, confirmed by a cell or tissue test. Must not need cancer treatment before surgery.
  • Give written consent and be able to follow study requirements. A legal representative may give consent when allowed.
  • Be able to care for yourself and be out of bed for at least half of your waking hours (ECOG score 0–2).
  • Meet minimum blood counts: infection-fighting cells at least 1.5 billion/L, platelets that help blood clot at least 100 billion/L, and hemoglobin at least 9 g/dL.
  • Meet kidney test limits: creatinine no more than 1.5 times the upper normal limit and kidney filtering rate at least 40 mL/min.
  • Meet liver test limits: bilirubin no more than 1.5 times the upper normal limit, and AST and ALT no more than 2.5 times that limit.
  • Have normal heart electrical timing (QTc) on a heart tracing: 350–450 milliseconds for men or 360–460 for women.

Who can't join

  • Have a condition that the study doctor believes could make participation unsafe or affect the study results.
  • Have colon or rectal cancer that has spread to distant parts of the body.
  • Have received chemotherapy before the planned colon cancer surgery.
  • Have a medical reason to avoid fluoxetine, including prolonged heart electrical timing (QTc).
  • Take tamoxifen, pimozide, or thioridazine.
  • Use other antidepressants or lithium at the time of the first biopsy, when a tissue sample is taken.
  • Have another active cancer or a history of cancer within the past 5 years. A history of skin cancer other than melanoma is allowed.

Simplified for readability. The official criteria below are what the study team uses.

Official 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)

Study sites (1)

CA