NCT05433402

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

Repurposing the Antipsychotic Drug Chlorpromazine as Adjuvant Therapeutic Agent for Resected Stage III Colon Cancer: A Pilot, Randomized, Open Label, Controlled Study.

• Status: Withdrawn
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Sadat City University · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Colon Cancer Stage III

Interventions

Type	Name	Description
DRUG	ChlorproMAZINE 50 MG	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
DRUG	Control	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)

Timeline

• Start date: 2022-07-20
• Primary completion: 2022-09-30
• Completion: 2022-09-30
• First posted: 2022-06-27
• Last updated: 2022-10-27

Locations

1 site across 1 country: Egypt