Ursodiol + Chemotherapy + Bevacizumab for Colorectal Cancer

Recruiting in Palo Alto (17 mi)

Overseen byLily L. Lai

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: City of Hope Medical Center

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

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.

Research Team

Lily L. Lai

Principal Investigator

City of Hope Medical Center

Eligibility Criteria

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.

Inclusion Criteria

I have advanced colorectal cancer confirmed by a biopsy.

I finished my last treatment 3 weeks ago and have recovered from side-effects.

I can carry out normal activities with minimal symptoms.

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Exclusion Criteria

I have not taken systemic steroids in the last 7 days.

I have lost more than 10% of my weight in the past 6 months.

I do not have any severe health or mental conditions that make treatment risky.

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Treatment Details

Interventions

Bevacizumab (Monoclonal Antibody)
Fluorouracil (Chemotherapy)
Leucovorin Calcium (Chemotherapy)
Oxaliplatin (Chemotherapy)
Ursodiol (Other)

Trial OverviewThe 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.

Participant Groups

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.

Bevacizumab is already approved in Japan, Canada for the following indications: