Sulfasalazine in Patients With Metastatic Colorectal Cancer

November 15, 2023 updated by: Reham Ameen El-Ghoneimy, Tanta University

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
    • El-Gharbia Governorate
      • Tanta, El-Gharbia Governorate, Egypt, 31527
        • Recruiting
        • Tanta university hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control Group
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.
Active Comparator: Sulfasalazine Group
This group will include 25 patients who will be scheduled to receive 6 cycles of 5-Fluorouracil and Oxaliplatin- based regimens every 2 weeks plus sulfasalazine (1 gram orally twice daily) for 3 months.
Drug: Sulfasalazine
Sulfasalazine is an anti-inflammatory drug that is indicated for treatment of ulcerative colitis and rheumatoid arthritis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluating the change in the serum level of Superoxide dismutase (SOD)
Time Frame: 3 months
Blood samples will be collected at baseline and 3 months after treatment.
3 months
Evaluating the change in the serum level of Nuclear factor-kappa B (NF-kB)
Time Frame: 3 months
Blood samples will be collected at baseline and 3 months after treatment.
3 months
Evaluating the change in the serum level of Ferritin
Time Frame: 3 months
Blood samples will be collected at baseline and 3 months after treatment.
3 months
Evaluating the change in the serum level of Bcl-2 associated X protein (Bax)
Time Frame: 3 months
Blood samples will be collected at baseline and 3 months after treatment.
3 months
Investigating the possible efficacy of sulfasalazine through evaluation of its impact on overall response rate (ORR).
Time Frame: 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.
3 months
Investigating the possible efficacy of sulfasalazine through evaluation of its impact on disease control rate (DCR).
Time Frame: 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.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluating the one-year overall survival (1-year OS)
Time Frame: 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.
12 months
Evaluating the progression free survival (PFS)
Time Frame: 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.
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
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.
3 months
Evaluating the safety and tolerability of sulfasalazine through investigating Liver function test.
Time Frame: 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.
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
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.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tanta University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2023

Primary Completion (Estimated)

September 1, 2025

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

November 5, 2023

First Submitted That Met QC Criteria

November 15, 2023

First Posted (Estimated)

November 16, 2023

Study Record Updates

Last Update Posted (Estimated)

November 16, 2023

Last Update Submitted That Met QC Criteria

November 15, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Sulfasalazine 2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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