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

Part of paid clinical trials in Duarte, California.

Sponsor
City of Hope Medical Center
Study ID
NCT00873275
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • bevacizumab — BIOLOGICAL
    5mg/kg IV day 1 and 15 of each 28 day course of treatment
  • FOLFOX regimen — DRUG
    Leucovorin, 5-FU and Oxaliplatin
  • fluorouracil — DRUG
    400 mg/m2 IV bolus immediately following leucovorin on days 1 and 15 of a 28 day course of treatment. Then 2.4 gm/m2 IV continuous infusion over 46 hours immediately following bolus dose on days 1 and 2 and 15 and 16 of a 28 day course of treatment
  • leucovorin calcium — DRUG
    400 mg/m2 IV infusion over 2 hours on days 1 and 15 of a 28 day course of treatment.
  • oxaliplatin — DRUG
    85 mg/m2 IV infusion over 2 hours on days 1 and 15 of a 28 day course of treatment.
  • ursodiol — DRUG
    Dose escalation in cohorts (3 patients/cohort) from an initial dose of 125 mg PO BID through 625 mgs PO BID beginning on Day -6 from infusion of bevacizumab and FOLFOX continuing for the duration of the treatment.
  • RNA analysis — GENETIC
    Analysis on discard tissues
  • gene expression analysis — GENETIC
    Determined in normal and malignant tissues in patients who undergo surgical resection after treatment on this trial
  • polymerase chain reaction — GENETIC
    Analysis on discard tissues
  • western blotting — GENETIC
    Determined on blood collected at Day -6, Day 0 and Day 7 (1 week after the first cycle of chemotherapy) from treatment and at the end of treatment
  • immunohistochemistry staining method — OTHER
    Performed on tumor blocks from the primary and the metastases from the patients on study
  • laboratory biomarker analysis — OTHER
    Performed on blood collected at Day -6, Day 0 and Day 7 (1 week after the first cycle of chemotherapy) from treatment and at the end of treatment
  • pharmacological study — OTHER
    Day 0, day 7 before treatment, 1/2 hour after the start of treatment, 1, 2, 3, 4, and 8 hours after the start of treatment.
  • positron emission tomography (PET) — PROCEDURE
    Patients will undergo PET scan imaging as part of their original staging or at baseline. If the PET scan was more than 2 weeks prior to Day 0 from study treatment, there will be a PET scan at Day 0. In any case there will be a PET scan when the patient completes treatment.

Study Details

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.

Key Dates

First listed
Apr 1, 2009
Start date
Mar 11, 2009
Status verified
Jun 2025
Primary completion
Sep 25, 2012
Completion
Feb 26, 2025

Study Design

Enrollment
11 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (ursodiol, combination chemotherapy, bevacizumab)
    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.

Primary Outcome Measure

Maximum-tolerated dose of ursodiol [ Time Frame: 28 days from the start of treatment ]

Locations (1)

FacilityCityStateZIPSite coordinators
City of Hope Medical CenterDuarteCalifornia91010-3000-

Find similar trials in Duarte, CA

By condition
Colorectal cancer
By specialty
OncologyGI oncology
By research site
City of Hope Medical Center· Duarte, CA

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