Repurposing the Antipsychotic Drug Chlorpromazine as Adjuvant Therapeutic Agent for Resected Stage III Colon Cancer

Study Overview
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Brief Summary
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chlorpromazine displays a series of remarkable bio-molecular effects in cancer cells, as inhibition of cell growth, nuclear aberrations, inhibition of the phosphoinositide 3-kinase/mammilian target of rapamycin (PI3K/mTOR) axis, induction of cytotoxic autophagy, inhibition of glutamate and DRD2 receptors. This study will evaluate the addition of chlorpromazine to the first-line therapeutic protocol in colon cancer stage III.

Official Title
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Repurposing the Antipsychotic Drug Chlorpromazine as Adjuvant Therapeutic Agent for Resected Stage III Colon Cancer: A Pilot, Randomized, Open Label, Controlled Study.

Conditions
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Colon Cancer Stage III

Intervention / Treatment
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* Drug: ChlorproMAZINE 50 MG
* Drug: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients age ≥18 years old. Patients with histologically confirmed surgically resected stage III colon cancer No rectal cancer Stage III disease (any pT, N1-2, M0) Patients should have a good performance status according to Eastern Cooperative Oncology Group (ECOG) score (ECOG 0-2). Patients with normal organic function as defined for the following criteria: Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 2.5 times the upper normal limit of the local laboratory (LSN-LL); Total serum bilirubin ≤ 2.0 x ULN-LL; Absolute neutrophil count ≥ 1,500 / mm3; Platelet count ≥ 100,000 / mm3; Hemoglobin ≥ 8.0 g / dl; Serum creatinine ≤ 1.5 x ULN-LL Patients should undergone curative-intent complete surgical resection Patients have at least one month from any major surgery to start of intervention Written informed consent before enrollment Exclusion Criteria: Patients with concurrent other malignancy or history of other malignancy treated within the past 3 years (other than non-melanoma skin cancer or in-situ cervical cancer) Patients with metastatic disease Patients who scheduled to receive any form of further adjuvant cancer therapy (A malignancy currently under active therapy Pregnant or breast-feeding patients Patients with known hypersensitivity or intolerance to CPZ Patients with serious illness or psychiatric condition. Patients have current participation in other protocols with experimental drugs. Patients with no ability to ingest food orally. Patients who have familial adenomatous polyposis, hereditary non-polyposis rectal cancer, or inflammatory bowel disease Patients who are taken other chemoprevention drugs (ex. NSAIDs, Aspirin)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br> | Drug: Control<br>* The control group will receive folinic acid, fluorouracil and oxaliplatin (mFOLFOX6) regimen every 14 days for (6-12 cycles) (6 months) (Day 1: 5-FU IV 400 mg/m2, leucovorin IV 400 mg/m2, oxaliplatin IV 85 mg/m2, 5-FU continuous IV infusion (CIVI) 1200 mg/m2/day x 2 days (over 46-48 hours)<br>|
| Experimental: Chloropromazine<br> | Drug: ChlorproMAZINE 50 MG<br>* The experimentall group will receive folinic acid, fluorouracil and oxaliplatin (mFOLFOX6) regimen every 14 days for (6-12 cycles) (6 months) (Day 1: 5-FU IV 400 mg/m2, leucovorin IV 400 mg/m2, oxaliplatin IV 85 mg/m2, 5-FU continuous IV infusion (CIVI) 1200 mg/m2/day x 2 days (over 46-48 hours) plus choloropromazine 50 mg daily for 6 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease-free survival | Disease-free survival as measured by Logrank | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | Overall survival as measured by Logrank | one year | 
| Time occurrence of new primary colon cancer and new polyps | Time occurrence of new primary colon cancer and new polyps as measured by Logrank | one year |