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

• Status: Not yet recruiting
• Trial end date: 2024-07-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sadat City University
• Treatments: Chlorpromazine

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)