Clinical trial · Interventional
Ursodiol, Combination Chemotherapy, and Bevacizumab in Treating Patients With Stage IV Colorectal Cancer
Phase I Study of Ursodeoxycholic Acid (Ursodiol)in Combination With 5-Fluorouracil, Leucovorin, Oxaliplatin and Bevacizumab in Patients With Metastatic Colorectal Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Drugs used in chemotherapy, such as ursodiol, oxaliplatin, leucovorin, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of colorectal cancer by blocking blood flow to the tumor. Giving ursodiol together with leucovorin calcium, fluorouracil, oxaliplatin, and bevacizumab may be an effective treatment for colorectal cancer. PURPOSE: This phase I trial is studying the side effects and best dose of ursodiol when given together with combination chemotherapy and bevacizumab in treating patients with stage IV colorectal cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (14)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bevacizumab | Biological | Bevacizumab | ALIAS |
| fluorouracil | Drug | Fluorouracil | ALIAS |
| FOLFOX regimen | Drug | FOLFOX Regimen | ALIAS |
| gene expression analysis | Genetic | — | UNRESOLVED |
| immunohistochemistry staining method | Other | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| leucovorin calcium | Drug | Leucovorin | ALIAS |
| oxaliplatin | Drug | Oxaliplatin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (ursodiol, combination chemotherapy, bevacizumab)
- description
- Patients receive oral ursodiol twice daily on days 1-28 (days -6 to 28 of course 1), leucovorin calcium IV over 2 hours on days 1 and 15, fluorouracil IV over 46 hours on days 1-2 and 15-16, and oxaliplatin IV over 2 hours and bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Biological: bevacizumab
- Drug: FOLFOX regimen
- Drug: fluorouracil
- Drug: leucovorin calcium
- Drug: oxaliplatin
- Drug: ursodiol
- Genetic: RNA analysis
- Genetic: gene expression analysis
- Genetic: polymerase chain reaction
- Genetic: western blotting
- Other: immunohistochemistry staining method
- Other: laboratory biomarker analysis
- Other: pharmacological study
- Procedure: positron emission tomography (PET)
Primary outcomes (5)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with advanced, biopsy proven metastatic colorectal cancer * Karnofsky Performance Status \>= 80 * Prior therapy completed at least 3 weeks before protocol treatment initiation with recovery from any side-effects * Serum albumin and prealbumin within normal limits * Alanine aminotransferase (ALT) within 3 x upper limit of normal * Alkaline phosphatase within 3 x upper limit of normal * Serum bilirubin within normal limits * Absolute neutrophil count \>= 1500/ul * Serum creatinine within 1.5 x upper limit of normal * Ability to understand and sign an institutional review board (IRB) approved informed consent * Ability to use appropriate contraception and no evidence of pregnancy in female patients of reproductive potential Exclusion Criteria: * Significant medical or psychiatric condition that would make treatment unsafe * Use of systemic steroids use within 7 days from start of trial * Nursing women * Patients unable to comply with protocol related studies and follow up * Weight loss of greater than 10% in the last 6 months
References
Publications (0)
Data not yet available