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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

Must not have

Weight loss of greater than 10% in the last 6 months

Nursing women

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Approved for 5 Other Conditions

No Placebo-Only Group

All Individual Drugs Already Approved

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I am currently breastfeeding.

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2020 Phase 1 & 2 trial • 88 Patients • NCT02012296

76%

Fatigue

58%

Hot flashes

30%

Diarrhea

30%

Pain

27%

Hyperglycemia

24%

Back pain

18%

Nausea

18%

Dizziness

18%

Dyspnea

18%

Arthralgia

15%

Anorexia

15%

Depression

15%

Anxiety

15%

Hypertension

15%

Edema limbs

15%

Headache

15%

Pain in extremity

12%

Urinary frequency

12%

Constipation

12%

Cough

12%

Fall

12%

Abdominal pain

12%

Arthritis

12%

Bone pain

Urinary incontinence

Insomnia

Flank pain

Generalized muscle weakness

Genital edema

Hematuria

Memory impairment

Platelet count decreased

Pruritis

Anemia

Renal calculi

Sinus disorder

Confusion

Dyspepsia

Muscle weakness lower limb

Peripheral sensory neuropathy

Renal and urinary disorders - Other

Skin and subcutaneous tissue disorders - Other

Vomiting

Alkaline phosphatase increase

Blood bilirubin increased

Blurred vision

Skin infection

Alopecia

Cystitis noninfective

Fracture

General disorders and administration site conditions - Other

Hypokalemia

Upper respiratory infection

Weight gain

Infections and infestations - Other

100%

80%

60%

40%

20%

Study treatment Arm

Treatment (Enzalutamide)

Treatment (Enzalutamide, Mifepristone)

Not Randomized

Awards & Highlights

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

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