Status:
WITHDRAWN
Repurposing the Antipsychotic Drug Chlorpromazine as Adjuvant Therapeutic Agent for Resected Stage III Colon Cancer
Lead Sponsor:
Sadat City University
Conditions:
Colon Cancer Stage III
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
PHASE2
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...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
July 20 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05433402
Start Date
July 20 2022
End Date
September 30 2022
Last Update
October 27 2022
Active Locations (1)
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1
Faculty of Pharmacy, University of Sadat city
Madīnat as Sādāt, Menoufia, Egypt, 13829