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

NCT05433402 | Withdrawn Phase 1 DMC

• 1 other identifier: Onco-2022-7
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Colon Cancer Stage III

Outcome Measures

Primary Outcomes (1)

• Disease-free survival

  Disease-free survival as measured by Logrank

  one year

Secondary Outcomes (2)

• Overall survival

  one year

• Time occurrence of new primary colon cancer and new polyps

  one year

Other Outcomes (1)

• Biological Markers

  6 months

Study Arms (2)

Control

ACTIVE COMPARATOR

Drug: Control

Chloropromazine

EXPERIMENTAL

Drug: ChlorproMAZINE 50 MG

Interventions

ChlorproMAZINE 50 MG DRUG

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

Chloropromazine

Control DRUG

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)

Control

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Sadat City University: lead

Study Sites (1)

Faculty of Pharmacy, University of Sadat city

Madīnat as Sādāt, Menoufia, 13829, Egypt

Location

MeSH Terms

Conditions

Colonic Neoplasms

Interventions

Chlorpromazine

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Phenothiazines; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: June 22, 2022
• First Posted: June 27, 2022
• Study Start: July 20, 2022
• Primary Completion: September 30, 2022
• Study Completion: September 30, 2022
• Last Updated: October 27, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF

Locations

EG (1)