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

Sadat City University

Status and phase

Withdrawn

Phase 2

Phase 1

Conditions

Colon Cancer Stage III

Treatments

Drug: ChlorproMAZINE 50 MG

Drug: Control

Study type

Interventional

Funder types

Other

Identifiers

NCT05433402

Onco-2022-7

Details and patient eligibility

About

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.

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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)