Status:
RECRUITING
Nitazoxanide in Patients With Metastatic Colorectal Cancer
Lead Sponsor:
Tanta University
Conditions:
Metastatic Colorectal Cancer
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
The aim of this study is to evaluate the potential efficacy and safety of nitazoxanide in patients with metastatic colorectal cancer.
Detailed Description
Globally, colorectal cancer (CRC) is a major malignant tumor of the gastrointestinal tract which originates from epithelial cells of the colon and rectum. The efficacy of current cancer therapies is s...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
March 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06049901
Start Date
March 1 2023
End Date
March 1 2026
Last Update
September 22 2023
Active Locations (1)
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1
Tanta University Hospital
Tanta, El-Gharbia Governorate, Egypt, 31527