Nitazoxanide in Patients With Metastatic Colorectal Cancer

NCT06049901 | Recruiting Phase 3

• 1 other identifier: Nitazoxanide in mCRC
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to evaluate the potential efficacy and safety of nitazoxanide in patients with metastatic colorectal cancer.

Conditions

Metastatic Colorectal Cancer

Keywords

Nitazoxanide

Outcome Measures

Primary Outcomes (5)

• Investigating the possible efficacy of nitazoxanide through evaluation of its impact on overall response rate (ORR) and disease control rate (DCR).

  Abdominal, pelvic and chest CT scanning will be performed at baseline and after 3 months. ORR and DCR will be evaluated and categorized according to the RECIST 1.1 criteria. ORR includes patients with both complete response and partial response. DCR includes patients with complete response, partial response and stable disease. Both ORR and DCR will be determined as number and percentage.

  3 months

• Evaluating the change in the serum level of Reduced glutathione (GSH)

  Blood samples will be collected at baseline and 3 months after treatment.

  3 months

• Evaluating the change in the serum level of Superoxide dismutase (SOD)

  Blood samples will be collected at baseline and 3 months after treatment.

  3 months

• Evaluating the change in the serum level of Nuclear factor-kappa B (NF-kB)

  Blood samples will be collected at baseline and 3 months after treatment.

  3 months

• Evaluating the change in the serum level of Protein disulfide isomerase (PDI)

  Blood samples will be collected at baseline and 3 months after treatment.

  3 months

Secondary Outcomes (5)

• Evaluating the one-year overall survival (1-year OS)

  12 months

• Evaluating the progression free survival (PFS)

  12 months

• Evaluating the safety and tolerability of nitazoxanide through investigating Liver function test (ALT (U/mL) and AST (U/mL)).

  3 months

• Evaluating the safety and tolerability of nitazoxanide through investigating Renal function test (SCr (mg/dL), BUN (mg/dL) and eCrCl (mL/min)).

  3 months

• Evaluating the safety and tolerability of nitazoxanide through investigating Hematological parameters (hemoglobin (mg/dL), erythrocytes (cells/μL), leukocytes (cells/μL), platelets (cells/μL) and ANC (cells/μL)).

  3 months

Study Arms (2)

Control Group

NO INTERVENTION

This group will include 30 patients who will be scheduled to receive 6 cycles of 5-Fluorouracil and Oxaliplatin- based regimens every 2 weeks for 3 months.

Nitazoxanide Group

ACTIVE COMPARATOR

This group will include 30 patients who will be scheduled to receive 6 cycles of 5-Fluorouracil and Oxaliplatin- based regimens every 2 weeks plus nitazoxanide (500 mg orally twice daily) for 3 months.

Drug: Nitazoxanide

Interventions

Nitazoxanide DRUG

Nitazoxanide is considered a broad-spectrum anti-microbial drug with a potent activity against various helminths, anaerobic bacteria and viruses.

Also known as: Nanazoxid

Nitazoxanide Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed diagnosis of stage IV (metastatic) CRC. Staging will be performed according to the American Joint Committee on Cancer (AJCC) 8th edition and will be documented by all investigating parameters of metastatic CRC
• Male or female patients with age range from 18-65 years old
• Women of childbearing age will be required to be on acceptable forms of contraception
• No contraindication to chemotherapy (absence of myelosuppression)
• Performance status \< 2 according to the Eastern Cooperative Oncology Group (ECOG) score
• Adequate liver function (alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \< grade 2) according to the National Cancer Institute-Common Terminology Criteria for Adverse Events, version 5.0 (NCI-CTCAE v 5.0)
• Adequate renal function (estimated creatinine clearance (eCrCl), serum creatinine (SCr) \< grade 2) according to NCI-CTCAE, v 5.0
• Adequate hematological parameters (hemoglobin, erythrocytes, platelets, leukocytes and absolute neutrophil count (ANC) \< grade 2 according to NCI-CTCAE, v 5.0

You may not qualify if:

• Pregnant or lactating women
• Patients who have known allergy to nitazoxanide or its metabolites
• Patients with concurrent active cancer originating from a primary site other than the colon or rectum
• Patients who are receiving highly plasma protein-bound drugs or drugs with extensive hepatic metabolism such as; coumarin anti-coagulants, oral hypoglycemic drugs and anti-epileptic drugs

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University Hospital

Tanta, El-Gharbia Governorate, 31527, Egypt

RECRUITING

Related Publications (3)

• Biller LH, Schrag D. Diagnosis and Treatment of Metastatic Colorectal Cancer: A Review. JAMA. 2021 Feb 16;325(7):669-685. doi: 10.1001/jama.2021.0106.

  PMID: 33591350 BACKGROUND

• Ripani P, Delp J, Bode K, Delgado ME, Dietrich L, Betzler VM, Yan N, von Scheven G, Mayer TU, Leist M, Brunner T. Thiazolides promote G1 cell cycle arrest in colorectal cancer cells by targeting the mitochondrial respiratory chain. Oncogene. 2020 Mar;39(11):2345-2357. doi: 10.1038/s41388-019-1142-6. Epub 2019 Dec 16.

  PMID: 31844249 BACKGROUND

• Shakya A, Bhat HR, Ghosh SK. Update on Nitazoxanide: A Multifunctional Chemotherapeutic Agent. Curr Drug Discov Technol. 2018;15(3):201-213. doi: 10.2174/1570163814666170727130003.

  PMID: 28748751 BACKGROUND

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

nitazoxanide

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Central Study Contacts

Reham A. El-Ghoneimy, M.Sc.

CONTACT

+201151896761; reham.elghonemy@pharm.tanta.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer of Clinical Pharmacy, Faculty of Pharmacy, Tanta University

Study Record Dates

• First Submitted: September 6, 2023
• First Posted: September 22, 2023
• Study Start: March 1, 2023
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2026
• Last Updated: September 22, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)