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Trial Title:
Sulfasalazine in Patients With Metastatic Colorectal Cancer
NCT ID:
NCT06134388
Condition:
Metastatic Colorectal Cancer
Conditions: Official terms:
Colorectal Neoplasms
Sulfasalazine
Conditions: Keywords:
Sulfasalazine
mCRC
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Sulfasalazine
Description:
Sulfasalazine is an anti-inflammatory drug that is indicated for treatment of ulcerative
colitis and rheumatoid arthritis.
Arm group label:
Sulfasalazine Group
Summary:
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
65 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Tanta University Hospital
Address:
City:
Tanta
Zip:
31527
Country:
Egypt
Status:
Recruiting
Start date:
September 1, 2023
Completion date:
September 2026
Lead sponsor:
Agency:
Tanta University
Agency class:
Other
Source:
Tanta University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06134388
