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

Phase 1

Withdrawn

• Conditions: Colon Cancer Stage III
• Interventions: Drug: Control; Drug: ChlorproMAZINE 50 MG

• Registration Number: NCT05433402
• Lead Sponsor: Sadat City University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-06-22
• Study First Submitted QC: 2022-06-22
• Study First Posted: 2022-06-27
• Study Start: 2022-07-20
• Primary Completion: 2022-09-30
• Study Completion: 2022-09-30
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-24
• Last Update Posted: 2022-10-27

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Control	-
Chloropromazine	ChlorproMAZINE 50 MG	-

Primary Outcome Measures

Name	Time	Method
Disease-free survival	one year	Disease-free survival as measured by Logrank

Secondary Outcome Measures

Name	Time	Method
Overall survival	one year	Overall survival as measured by Logrank
Time occurrence of new primary colon cancer and new polyps	one year	Time occurrence of new primary colon cancer and new polyps as measured by Logrank

Trial Locations

Locations (1)

Faculty of Pharmacy, University of Sadat city; 🇪🇬 Sadat City, Menoufia, Egypt