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

Colon Cancer Stage III Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05433402
• Other study ID #: Onco-2022-7
• Status: Withdrawn
• Phase: Phase 1/Phase 2
• Start date: July 20, 2022
• Est. completion date: September 30, 2022

Study information

• Verified date: October 2022
• Source: Sadat City University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 30, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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)

Related Conditions & MeSH terms

• Colon Cancer Stage III
• Colonic Neoplasms

Intervention

Drug:
• ChlorproMAZINE 50 MG
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
• Control
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)

Locations

Country	Name	City	State
Egypt	Faculty of Pharmacy, University of Sadat city	Sadat City	Menoufia

Sponsors (1)

Lead Sponsor	Collaborator
Sadat City University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Biological Markers	Blood and serum level of apoptotic and inflammatory markers (Sirtuin 1 (SIRT1) - p53 - TNF-a - Caspase 3)	6 months
Primary	Disease-free survival	Disease-free survival as measured by Logrank	one year
Secondary	Overall survival	Overall survival as measured by Logrank	one year
Secondary	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