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New treatment option for Colorectal Adenocarcinoma
Official title Fluoxetine for the Modification of Colorectal Tumor Immune Cells Before Surgery in Patients With Colorectal Cancer
ClinicalTrials.gov ID: NCT06225011
What this study is testing
What is Fluoxetine?
Fluoxetine is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for colorectal adenocarcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- World Health Organization (WHO) Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Absolute neutrophil count (ANC) ≥ 1.5x10\^9/L
You likely can't join if
- 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...
- 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
See the full eligibility 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
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.