Colon Cancer Stage III Clinical Trial
Official title:
Repurposing the Antipsychotic Drug Chlorpromazine as Adjuvant Therapeutic Agent for Resected Stage III Colon Cancer: A Pilot, Randomized, Open Label, Controlled Study.
Verified date | October 2022 |
Source | Sadat City University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | September 30, 2022 |
Est. primary completion date | September 30, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
Egypt | Faculty of Pharmacy, University of Sadat city | Sadat City | Menoufia |
Lead Sponsor | Collaborator |
---|---|
Sadat City University |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Biological Markers | Blood and serum level of apoptotic and inflammatory markers (Sirtuin 1 (SIRT1) - p53 - TNF-a - Caspase 3) | 6 months | |
Primary | Disease-free survival | Disease-free survival as measured by Logrank | one year | |
Secondary | Overall survival | Overall survival as measured by Logrank | one year | |
Secondary | Time occurrence of new primary colon cancer and new polyps | Time occurrence of new primary colon cancer and new polyps as measured by Logrank | one year |
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