Ursodiol, Combination Chemotherapy, and Bevacizumab in Treating Patients With Stage IV Colorectal Cancer

• Status: Active, not recruiting
• Trial end date: 2025-01-13
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: City of Hope Medical Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Bevacizumab; Calcium; Fluorouracil; Leucovorin; Levoleucovorin; Oxaliplatin; Ursodeoxycholic Acid

Criteria

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