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NCT Number: NCT06134388

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.

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Key information

Conditions

Metastatic Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Tanta University Hospital

Tanta, El-Gharbia Governorate, 31527, Egypt

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sulfasalazine

Drug

Sulfasalazine is an anti-inflammatory drug that is indicated for treatment of ulcerative colitis and rheumatoid arthritis.

Primary outcomes

  1. 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.

  2. 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. 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.

  4. 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.

  5. 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.

  6. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

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

CONTACT

[email protected]

+201151896761

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Nov 18, 2023
Registry last updated
Nov 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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