NCT00873275CompletedPhase 1
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 · Last updated 22 Jun 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 11 (actual)
- First submitted
- 31 Mar 2009
- Start date
- Mar 2009
- Primary completion date
- Sept 2012
- Lead sponsor
- City of Hope Medical Center
- Diseases
- Colorectal cancer
- NCT number
- NCT00873275
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 11
- From Mar 2009 to the primary completion date, Sept 2012
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of systemic steroids use within 7 days from start of trial
Other illness
- Significant medical or psychiatric condition that would make treatment unsafe
Other
- Nursing women
- Patients unable to comply with protocol related studies and follow up
- Weight loss of greater than 10% in the last 6 months
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| City of Hope Medical Center Coordinator of this site? Confirm its status | Duarte | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.