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

Primary Purpose

Colon Cancer Stage III

Status
Withdrawn
Phase
Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
ChlorproMAZINE 50 MG
Control
Sponsored by
Sadat City University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colon Cancer Stage III

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept 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)

Sites / Locations

  • Faculty of Pharmacy, University of Sadat city

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control

Chloropromazine

Arm Description

Outcomes

Primary Outcome Measures

Disease-free survival
Disease-free survival as measured by Logrank

Secondary Outcome Measures

Overall survival
Overall survival as measured by Logrank
Time occurrence of new primary colon cancer and new polyps
Time occurrence of new primary colon cancer and new polyps as measured by Logrank

Full Information

First Posted
June 22, 2022
Last Updated
October 24, 2022
Sponsor
Sadat City University
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1. Study Identification

Unique Protocol Identification Number
NCT05433402
Brief Title
Repurposing the Antipsychotic Drug Chlorpromazine as Adjuvant Therapeutic Agent for Resected Stage III Colon Cancer
Official Title
Repurposing the Antipsychotic Drug Chlorpromazine as Adjuvant Therapeutic Agent for Resected Stage III Colon Cancer: A Pilot, Randomized, Open Label, Controlled Study.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Withdrawn
Why Stopped
Organizational safety isues
Study Start Date
July 20, 2022 (Actual)
Primary Completion Date
September 30, 2022 (Actual)
Study Completion Date
September 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sadat City University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Cancer Stage III

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Active Comparator
Arm Title
Chloropromazine
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
ChlorproMAZINE 50 MG
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Control
Intervention Description
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)
Primary Outcome Measure Information:
Title
Disease-free survival
Description
Disease-free survival as measured by Logrank
Time Frame
one year
Secondary Outcome Measure Information:
Title
Overall survival
Description
Overall survival as measured by Logrank
Time Frame
one year
Title
Time occurrence of new primary colon cancer and new polyps
Description
Time occurrence of new primary colon cancer and new polyps as measured by Logrank
Time Frame
one year
Other Pre-specified Outcome Measures:
Title
Biological Markers
Description
Blood and serum level of apoptotic and inflammatory markers (Sirtuin 1 (SIRT1) - p53 - TNF-α - Caspase 3)
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
Faculty of Pharmacy, University of Sadat city
City
Sadat City
State/Province
Menoufia
ZIP/Postal Code
13829
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

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

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