Clinical trial NCT05433402: 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
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: Colon Cancer Stage III
Lead sponsor: Sadat City University
Sponsor class: OTHER
First posted: 2022-06-27
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: Disease-free survival
timeFrame: one year
Secondary outcomes:
measure: Overall survival
timeFrame: one year
measure: Time occurrence of new primary colon cancer and new polyps
timeFrame: one year
Other outcomes:
measure: Biological Markers
timeFrame: 6 months
Locations:
city: Sadat City
country: Egypt
facility: Faculty of Pharmacy, University of Sadat city
state: Menoufia
Study officials:
References: