Using Nitazoxanide for Metastatic Colorectal Cancer

Clinical Study Evaluating the Efficacy and Safety of Nitazoxanide in Patients With Metastatic Colorectal Cancer

This study is testing if nitazoxanide, a drug usually used for infections, can help people with metastatic colorectal cancer feel better and have more treatment options.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Tanta University (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Tanta, El-Gharbia Governorate)
• Trial ID: NCT06049901 on ClinicalTrials.gov

What this trial studies

This study evaluates the efficacy and safety of nitazoxanide, a broad-spectrum anti-microbial drug, in patients with metastatic colorectal cancer (CRC). The research focuses on repurposing nitazoxanide, which has shown potential to inhibit the proliferation of CRC cell lines at concentrations typically used for anti-parasitic activity. Participants will be closely monitored for both therapeutic effects and any adverse reactions during the treatment phase. The study aims to provide a new treatment option for patients facing limited efficacy from current therapies.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-65 with histologically confirmed stage IV metastatic colorectal cancer and no contraindications to chemotherapy.

Not a fit: Patients with significant myelosuppression or those with performance status greater than 2 according to the ECOG score may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a new therapeutic option for patients with metastatic colorectal cancer, potentially improving outcomes and quality of life.

How similar studies have performed: While the repurposing of existing drugs like nitazoxanide for cancer treatment is a novel approach, similar studies have shown promise in other contexts, suggesting potential for success.

Eligibility criteria

Inclusion Criteria:

1. 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
2. Male or female patients with age range from 18-65 years old
3. Women of childbearing age will be required to be on acceptable forms of contraception
4. No contraindication to chemotherapy (absence of myelosuppression)
5. Performance status \< 2 according to the Eastern Cooperative Oncology Group (ECOG) score
6. 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)
7. Adequate renal function (estimated creatinine clearance (eCrCl), serum creatinine (SCr) \< grade 2) according to NCI-CTCAE, v 5.0
8. Adequate hematological parameters (hemoglobin, erythrocytes, platelets, leukocytes and absolute neutrophil count (ANC) \< grade 2 according to NCI-CTCAE, v 5.0

Exclusion Criteria:

1. Pregnant or lactating women
2. Patients who have known allergy to nitazoxanide or its metabolites
3. Patients with concurrent active cancer originating from a primary site other than the colon or rectum
4. 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

Where this trial is running

Tanta, El-Gharbia Governorate

• Tanta University Hospital — Tanta, El-Gharbia Governorate, Egypt (Recruiting)

Study contacts

• Study coordinator: Reham A. El-Ghoneimy, M.Sc.

Conditions Metastatic Colorectal Cancer; Nitazoxanide