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

Sponsor
Sadat City University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05433402
Collaborator
(none)
70
Enrollment
1
Location
2
Arms
24.4
Anticipated Duration (Months)
2.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
70 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Repurposing the Antipsychotic Drug Chlorpromazine as Adjuvant Therapeutic Agent for Resected Stage III Colon Cancer: A Pilot, Randomized, Open Label, Controlled Study.
Anticipated Study Start Date :
Jul 20, 2022
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Jul 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Control

Drug: 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)
Experimental: Chloropromazine

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

Outcome Measures

Primary Outcome Measures

  1. Disease-free survival [one year]

    Disease-free survival as measured by Logrank

Secondary Outcome Measures

  1. Overall survival [one year]

    Overall survival as measured by Logrank

  2. 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

Other Outcome Measures

  1. Biological Markers [6 months]

    Blood and serum level of apoptotic and inflammatory markers (Sirtuin 1 (SIRT1) - p53 - TNF-α - Caspase 3)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Faculty of Pharmacy, University of Sadat city Sadat City Menoufia Egypt 13829

Sponsors and Collaborators

  • Sadat City University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mahmoud Samy Abdallah, Principle Investigator, Sadat City University
ClinicalTrials.gov Identifier:
NCT05433402
Other Study ID Numbers:
  • Onco-2022-7
First Posted:
Jun 27, 2022
Last Update Posted:
Jun 27, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Colonic Neoplasms
Chlorpromazine

Study Results

No Results Posted as of Jun 27, 2022