The aim of this study is to evaluate the potential efficacy and safety of sulfasalazine in patients with metastatic colorectal cancer.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Sulfasalazine is an anti-inflammatory drug that is indicated for treatment of ulcerative colitis and rheumatoid arthritis.
Tanta University Hospital
Tanta, El-Gharbia Governorate, Egypt
RECRUITINGEvaluating the change in the serum level of Ferritin
Blood samples will be collected at baseline and 3 months after treatment.
Time frame: 3 months
Evaluating the change in the serum level of Superoxide dismutase (SOD)
Blood samples will be collected at baseline and 3 months after treatment.
Time frame: 3 months
Evaluating the change in the serum level of Nuclear factor-kappa B (NF-kB)
Blood samples will be collected at baseline and 3 months after treatment.
Time frame: 3 months
Evaluating the change in the serum level of Bcl-2 associated X protein (Bax)
Blood samples will be collected at baseline and 3 months after treatment.
Time frame: 3 months
Investigating the possible efficacy of sulfasalazine through evaluation of its impact on overall response rate (ORR).
Abdominal, pelvic and chest CT scanning will be performed at baseline and after 3 months. ORR will be evaluated and categorized according to the RECIST 1.1 criteria. ORR includes patients with both complete response and partial response. ORR will be determined as number and percentage.
Time frame: 3 months
Investigating the possible efficacy of sulfasalazine through evaluation of its impact on disease control rate (DCR).
Abdominal, pelvic and chest CT scanning will be performed at baseline and after 3 months. DCR will be evaluated and categorized according to the RECIST 1.1 criteria. DCR includes patients with complete response, partial response and stable disease. DCR will be determined as number and percentage.
Time frame: 3 months
Reham A. El-Ghoneimy, M.Sc in Clinical Pharmacy
CONTACT
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Evaluating the progression free survival (PFS)
PFS is defined as the time from randomization to investigator- assessed tumor progression. PFS will be determined as mean and median in months.
Time frame: 12 months
Evaluating the one-year overall survival (1-year OS)
OS is defined as the time from randomization to death from any cause is OS. One-year OS will be determined as mean and median in months.
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)).
These parameters will be followed up at baseline and 3 months after treatment. The reported adverse effects will be graded according to the National Cancer Institute- Common Terminology Criteria for Adverse Effects ( NCI-CTCAE) version 5.
Time frame: 3 months
Evaluating the safety and tolerability of sulfasalazine through investigating Liver function test.
These parameters will be followed up at baseline and 3 months after treatment. The reported adverse effects will be graded according to the National Cancer Institute- Common Terminology Criteria for Adverse Effects ( NCI-CTCAE) version 5.
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)).
These parameters will be followed up at baseline and 3 months after treatment. The reported adverse effects will be graded according to the National Cancer Institute- Common Terminology Criteria for Adverse Effects ( NCI-CTCAE) version 5.
Time frame: 3 months