Recruiting NCT06134388
Sulfasalazine in Patients With Metastatic Colorectal Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Sulfasalazine.
- Who it may be relevant to
- Registry conditions: Metastatic Colorectal Cancer. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Clinical Study Evaluating the Efficacy and Safety of Sulfasalazine in Patients With Metastatic Colorectal Cancer
Overview
The aim of this study is to evaluate the potential efficacy and safety of sulfasalazine in patients with metastatic colorectal cancer.
Detailed description
Sulfasalazine is an anti-inflammatory drug that is indicated for treatment of ulcerative colitis and rheumatoid arthritis. Sulfasalazine decreased the risk of ulcerative colitis-related colorectal cancer through its anti-inflammatory effect and induction of oxidative stress in cancer cells. Furthermore, intact sulfasalazine, but not its metabolites, inhibited the growth and metastasis various cancers.
Interventions
- Drug Sulfasalazine
Sulfasalazine is an anti-inflammatory drug that is indicated for treatment of ulcerative colitis and rheumatoid arthritis.
Primary outcome measures
- Evaluating the change in the serum level of Ferritin [Time frame: 3 months]
- Evaluating the change in the serum level of Superoxide dismutase (SOD) [Time frame: 3 months]
- Evaluating the change in the serum level of Nuclear factor-kappa B (NF-kB) [Time frame: 3 months]
- Evaluating the change in the serum level of Bcl-2 associated X protein (Bax) [Time frame: 3 months]
- Investigating the possible efficacy of sulfasalazine through evaluation of its impact on overall response rate (ORR). [Time frame: 3 months]
- Investigating the possible efficacy of sulfasalazine through evaluation of its impact on disease control rate (DCR). [Time frame: 3 months]
Secondary outcome measures (5)
- Evaluating the progression free survival (PFS) [Time frame: 12 months]
- Evaluating the one-year overall survival (1-year OS) [Time frame: 12 months]
- Evaluating the safety and tolerability of sulfasalazine through investigating Hematological parameters (hemoglobin (mg/dL), erythrocytes (cells/μL), leukocytes (cells/μL), platelets (cells/μL) and absolute neutrophil count (cells/μL)). [Time frame: 3 months]
- Evaluating the safety and tolerability of sulfasalazine through investigating Liver function test. [Time frame: 3 months]
- Evaluating the safety and tolerability of sulfasalazine through investigating Renal function test (serum creatinine (mg/dL), blood urea nitrogen (mg/dL) and creatinine clearance (mL/min)). [Time frame: 3 months]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Tanta University Hospital — Tanta
Publications
- Ma MZ, Chen G, Wang P, Lu WH, Zhu CF, Song M, Yang J, Wen S, Xu RH, Hu Y, Huang P. Xc- inhibitor sulfasalazine sensitizes colorectal cancer to cisplatin by a GSH-dependent mechanism. Cancer Lett. 2015 Nov 1;368(1):88-96. doi: 10.1016/j.canlet.2015.07.031. Epub 2015 Aug 5. PMID 26254540
- Yin L, Liu P, Jin Y, Ning Z, Yang Y, Gao H. Ferroptosis-related small-molecule compounds in cancer therapy: Strategies and applications. Eur J Med Chem. 2022 Dec 15;244:114861. doi: 10.1016/j.ejmech.2022.114861. Epub 2022 Oct 22. PMID 36332549
- Narang VS, Pauletti GM, Gout PW, Buckley DJ, Buckley AR. Sulfasalazine-induced reduction of glutathione levels in breast cancer cells: enhancement of growth-inhibitory activity of Doxorubicin. Chemotherapy. 2007;53(3):210-7. doi: 10.1159/000100812. Epub 2007 Mar 15. PMID 17356269
Identifiers
NCT: NCT06134388 · Sulfasalazine 2023