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WithdrawnNCT05433402Updated Oct 27, 2022

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

A Phase 1/2 interventional study of ChlorproMAZINE 50 MG and Control in Colon Cancer Stage III, sponsored by Sadat City University. Withdrawn at 1 site in Egypt. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2022-10-27.

Sponsored by Sadat City University · Phase 1/2, Interventional, and Treatment

Why this study was withdrawn
Organizational safety isues
Phase
Phase 1/2
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
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Study 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.

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Conditions studied

  • Colon Cancer Stage III

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In context

Colonic Neoplasms

1,485 studies on the registry are indexed under Colonic Neoplasms; 362 are open to participants now.

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Lead sponsor

Sadat City University is the lead sponsor of 25 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

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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

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)
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Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Active comparator
    Control

    Drug: Control

  • Experimental
    Chloropromazine

    Drug: ChlorproMAZINE 50 MG

Interventions

  • 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

  • DrugControl

    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)

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What researchers measure

Primary outcomes

  1. Disease-free survival

    Disease-free survival as measured by Logrank

    Time frame: one year

Secondary outcomes

  1. Overall survival

    Overall survival as measured by Logrank

    Time frame: one year

  2. Time occurrence of new primary colon cancer and new polyps

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

    Time frame: one year

Other outcomes

  1. Biological Markers

    Blood and serum level of apoptotic and inflammatory markers (Sirtuin 1 (SIRT1) - p53 - TNF-α - Caspase 3)

    Time frame: 6 months

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Study locations

1 site
  • Faculty of Pharmacy, University of Sadat city
    Madīnat as Sādāt, Menoufia 13829, Egypt
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References and documents

Individual participant data

Plan to share: Yes

Supporting information: Study protocol, Informed consent form

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 27, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05433402
Lead sponsor
Sadat City University
Responsible party
Mahmoud Samy Abdallah (Principle Investigator, Sadat City University) — Principal investigator
First posted
Jun 27, 2022
Start date
Jul 20, 2022
Primary completion
Sep 30, 2022
Completion
Sep 30, 2022
Last update
Oct 27, 2022

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is withdrawn, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Chlorpromazine

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