Overview

Eligibility

Design Details

Arms & Interventions

Outcome Measures

Trial Sites

Source: NCT06134388

Recruiting

Sulfasalazine in Patients With Metastatic Colorectal Cancer

Interventional

Phase 3

Tanta University Hospital

Sponsor: Tanta University

Last Updated: November 18, 2023

Notice- Information is sourced from public registries and may not reflect real-time changes at the local site.

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

Show Detailed Description

Treatment Category

Antibiotics

Required Mutations

None

Trial Started

September 1, 2023

Last Updated by Sponsor

November 18, 2023

Estimated Completion

September 1, 2025

Contact Study

Name:Reham A. El-Ghoneimy, M.Sc in Clinical Pharmacy

Email:reham.elghonemy@pharm.tanta.edu.eg

Phone:+201151896761

Eligibility

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

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Design Details

AllocationRandomized

Intervention ModelParallel Assignment

MaskingNone (Open Label)

Number to Enroll50

Arms & Interventions

Arms

Interventions

Type: No Intervention

Description: This group will include 25 patients who will be scheduled to receive 6 cycles of 5-Fluorouracil and Oxaliplatin- based regimens every 2 weeks for 3 months.

Interventions:

Sulfasalazine

Outcome Measures

Primary Outcome Measures

Evaluating the change in the serum level of Superoxide dismutase (SOD)3 months

Blood samples will be collected at baseline and 3 months after treatment.

Evaluating the change in the serum level of Nuclear factor-kappa B (NF-kB)3 months

Blood samples will be collected at baseline and 3 months after treatment.

Evaluating the change in the serum level of Ferritin3 months

Blood samples will be collected at baseline and 3 months after treatment.

Evaluating the change in the serum level of Bcl-2 associated X protein (Bax)3 months

Blood samples will be collected at baseline and 3 months after treatment.

Investigating the possible efficacy of sulfasalazine through evaluation of its impact on overall response rate (ORR).3 months

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.

Investigating the possible efficacy of sulfasalazine through evaluation of its impact on disease control rate (DCR).3 months

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.

Secondary Outcome Measures

Evaluating the one-year overall survival (1-year OS)12 months

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.

Evaluating the progression free survival (PFS)12 months

PFS is defined as the time from randomization to investigator- assessed tumor progression. PFS will be determined as mean and median in 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)).3 months

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.

Evaluating the safety and tolerability of sulfasalazine through investigating Liver function test.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)).3 months

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Trial Sites

This study has 1 trial site

Tanta University Hospital

Tanta, El-Gharbia Governorate, EG

Recruiting

Tanta, El-Gharbia Governorate, 31527 EG

Tanta University Hospital

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