Sulfasalazine in Patients With Metastatic Colorectal Cancer

Recruiting · NCT06134388 · Interventional (participants receive a specific treatment) · Lead sponsor: Tanta University

Interventions studied

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

Age range

18 Years to 65 Years

Sex

All (male and female)

Healthy volunteers

No - a diagnosis or condition is required

Phase

Phase 3

Study type

Interventional (participants receive a specific treatment)

Histologically confirmed diagnosis of stage IV (metastatic) colorectal cancer. 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 colorectal cancer
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
Performance status \< 2 according to the Eastern Cooperative Oncology Group (ECOG) score
No contraindication to chemotherapy (absence of myelosuppression)
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

Pregnant or lactating women
Patients with concurrent active cancer originating from a primary site other than the colon or rectum
Patients who have known allergy to sulfasalazine or its metabolites
Patients with nephrolithiasis, severe vomiting or severe diarrhea
Patients who are receiving highly plasma protein-bound drugs or drugs with extensive hepatic metabolism such as; coumarin anti-coagulants
Patients with intestinal or urinary obstruction
Patients with known glucose-6-phosphate dehydrogenase deficiency or porphyria
Ongoing treatment with sulfasalazine or mesalamine for ulcerative colitis or rheumatoid arthritis

1 location listed.