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Monoclonal Antibody

Ursodiol + Chemotherapy + Bevacizumab for Colorectal Cancer

Phase 1
Waitlist Available
Led By Lily L. Lai, MD
Research Sponsored by City of Hope Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients with advanced, biopsy proven metastatic colorectal cancer
Prior therapy completed at least 3 weeks before protocol treatment initiation with recovery from any side-effects
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 days after start of treatment during course 1
Awards & highlights

Study Summary

This trial is studying the side effects and best dose of the drug ursodiol when given together with combination chemotherapy (leucovorin calcium, fluorouracil, and oxaliplatin) and bevacizumab in treating patients with stage IV colorectal cancer.

Who is the study for?
This trial is for adults with advanced, biopsy-confirmed metastatic colorectal cancer. Participants must have normal levels of certain blood proteins and liver enzymes, a specific white blood cell count, and kidney function within set limits. They should be in good physical condition (Karnofsky Performance Status >= 80), not have had recent significant weight loss, and must agree to use contraception if applicable.Check my eligibility
What is being tested?
The study tests the effectiveness of combining ursodiol with FOLFOX chemotherapy (fluorouracil, leucovorin calcium, oxaliplatin) and bevacizumab antibody treatment in stage IV colorectal cancer patients. It aims to find the best dose of ursodiol that's safe when used with this regimen.See study design
What are the potential side effects?
Potential side effects include those common to chemotherapy such as nausea, fatigue, hair loss; from bevacizumab like bleeding or hypertension; plus any related to liver function due to ursodiol. The exact side effects will vary by individual.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have advanced colorectal cancer confirmed by a biopsy.
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I finished my last treatment 3 weeks ago and have recovered from side-effects.
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I can carry out normal activities with minimal symptoms.
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I am not pregnant and can use birth control.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 days after start of treatment during course 1
This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 days after start of treatment during course 1 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Maximum-tolerated dose of ursodiol
Pharmacokinetics of ursodiol
Survival
+2 more

Side effects data

From 2020 Phase 1 & 2 trial • 88 Patients • NCT02012296
64%
Fatigue
27%
Hot flashes
23%
Anorexia
18%
Upper respiratory infection
18%
Peripheral sensory neuropathy
18%
Anxiety
14%
Pain
14%
Nausea
14%
Arthralgia
14%
Diarrhea
14%
Constipation
14%
Vomiting
9%
Edema limbs
9%
Weight loss
9%
Blurred vision
9%
Bone pain
9%
Hypertension
9%
Abdominal pain
9%
Anemia
9%
Headache
9%
General disorders and administration site conditions - Other
9%
Pelvic pain
9%
Dyspnea
9%
Skin infection
9%
Non-cardiac chest pain
5%
Generalized muscle weakness
5%
Neoplasms benign, malignant and unspecified
5%
Back pain
5%
Insomnia
5%
Atrial fibrillation
5%
Heart failure
5%
Arthritis
5%
Confusion
5%
Cough
5%
Depression
5%
Dizziness
5%
Hyperglycemia
5%
Pruritis
5%
Renal and urinary disorders - Other
5%
Skin and subcutaneous tissue disorders - Other
5%
Cystitis noninfective
5%
Flu like symptoms
100%
80%
60%
40%
20%
0%
Study treatment Arm
Not Randomized
Treatment (Enzalutamide, Mifepristone)
Treatment (Enzalutamide)

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (ursodiol, combination chemotherapy, bevacizumab)Experimental Treatment14 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bevacizumab
FDA approved
FOLFOX regimen
2009
Completed Phase 3
~2440
Fluorouracil
FDA approved
Leucovorin
FDA approved
Oxaliplatin
FDA approved
RNA analysis
2011
Completed Phase 2
~880
gene expression analysis
2006
Completed Phase 2
~2030
polymerase chain reaction
2006
Completed Phase 2
~1700
western blotting
2006
Completed Phase 2
~900

Find a Location

Who is running the clinical trial?

City of Hope Medical CenterLead Sponsor
558 Previous Clinical Trials
1,917,441 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,609 Previous Clinical Trials
40,915,635 Total Patients Enrolled
Lily L. Lai, MDPrincipal InvestigatorCity of Hope Medical Center

Media Library

Bevacizumab (Monoclonal Antibody) Clinical Trial Eligibility Overview. Trial Name: NCT00873275 — Phase 1
Colorectal Cancer Research Study Groups: Treatment (ursodiol, combination chemotherapy, bevacizumab)
Colorectal Cancer Clinical Trial 2023: Bevacizumab Highlights & Side Effects. Trial Name: NCT00873275 — Phase 1
Bevacizumab (Monoclonal Antibody) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00873275 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there presently opportunities to join this research endeavor?

"Unfortunately, at the present time this trial is not accepting new participants. The initial posting was on March 11th 2009 and it underwent its most recent edit on November 22nd 2022. If you're seeking other trials of interest, there are 1064 studies for colorectal cancer currently recruiting and 836 drug-focused investigations in search of volunteers."

Answered by AI

To what extent are individuals safeguarded in pharmacological research?

"Our team at Power assigned the pharmacological study a score of 1 on our safety rating scale, as it is currently in its initial trial phase with limited research supporting both efficacy and safety."

Answered by AI

Has any additional research been conducted on pharmaceuticals in relation to this subject?

"Currently, there are 836 studies being conducted on pharmacological study with 262 of them in Phase 3. Although Guangzhou and Guangdong house the majority of these experiments, trials for this research topic can be found at 37 410 locations across the world."

Answered by AI

To what end is a pharmacological study typically conducted?

"Malignant neoplasms can often be managed with pharmacological study. This method of treatment may also prove useful for those struggling with recurrent platinum sensitive primary peritoneal cancer, rectal carcinoma, and locally advanced nonsquamous non-small cell lung cancer."

Answered by AI

How many individuals are eligible to partake in this research endeavor?

"This clinical trial is not presently looking for people to participate. It was initially posted on March 11, 2009 and its last update occurred on November 22, 2022. For those searching for alternative research projects, 1064 studies are actively recruiting colorectal cancer patients while 836 trials seek volunteers for pharmacological experiments."

Answered by AI
~1 spots leftby Mar 2025