Using sulfasalazine to treat metastatic colorectal cancer

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

This study is testing if the anti-inflammatory drug sulfasalazine can help people with metastatic colorectal cancer by slowing down cancer growth and spread.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Tanta University (other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Tanta, El-Gharbia Governorate)
• Trial ID: NCT06134388 on ClinicalTrials.gov

What this trial studies

This study evaluates the efficacy and safety of sulfasalazine, an anti-inflammatory drug, in patients diagnosed with metastatic colorectal cancer. The research focuses on how sulfasalazine may inhibit cancer growth and metastasis, leveraging its known effects from treating ulcerative colitis and rheumatoid arthritis. Participants will be closely monitored for both therapeutic outcomes and potential side effects throughout the trial.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-65 with histologically confirmed stage IV metastatic colorectal cancer and an ECOG performance status of less than 2.

Not a fit: Patients with significant myelosuppression or contraindications to chemotherapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with metastatic colorectal cancer.

How similar studies have performed: While sulfasalazine has shown promise in reducing cancer risk in ulcerative colitis patients, this specific application in metastatic colorectal cancer is novel and has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

1. 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
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. Performance status \< 2 according to the Eastern Cooperative Oncology Group (ECOG) score
5. No contraindication to chemotherapy (absence of myelosuppression)
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 with concurrent active cancer originating from a primary site other than the colon or rectum
3. Patients who have known allergy to sulfasalazine or its metabolites
4. Patients with nephrolithiasis, severe vomiting or severe diarrhea
5. Patients who are receiving highly plasma protein-bound drugs or drugs with extensive hepatic metabolism such as; coumarin anti-coagulants
6. Patients with intestinal or urinary obstruction
7. Patients with known glucose-6-phosphate dehydrogenase deficiency or porphyria
8. Ongoing treatment with sulfasalazine or mesalamine for ulcerative colitis or rheumatoid arthritis

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 in Clinical Pharmacy

Conditions: Metastatic Colorectal Cancer, Sulfasalazine, mCRC