Combination Chemotherapy and Bevacizumab With or Without PRI-724 in Treating Patients With Newly Diagnosed Metastatic Colorectal Cancer

Part of paid clinical trials in Los Angeles, California.

Sponsor
University of Southern California
Study ID
NCT02413853
Phase
PHASE2
Status
Withdrawn

Conditions

  • Colorectal Adenocarcinoma
  • Stage IVA Colorectal Cancer
  • Stage IVB Colorectal Cancer

Eligibility Criteria

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

Interventions

  • CBP/beta-catenin Antagonist PRI-724 — DRUG
    Given IV
  • Bevacizumab — BIOLOGICAL
    Given IV
  • Leucovorin Calcium — DRUG
    Given IV
  • Oxaliplatin — DRUG
    Given IV
  • Fluorouracil — DRUG
    Given IV
  • Laboratory Biomarker Analysis — OTHER
    Correlative studies

Study Details

This randomized phase II trial studies how well combination chemotherapy and bevacizumab with or without CBP/beta-catenin antagonist PRI-724 (PRI-724) works in treating patients with newly diagnosed colorectal cancer that has spread to other places in the body. Drugs used in chemotherapy, such as leucovorin calcium, oxaliplatin, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as bevacizumab, may block tumor growth in different ways by targeting certain cells. PRI-724 may help stop the growth of cancer cells by blocking the specific signaling pathway that cancer cells need to grow and spread. It is not yet known whether combination chemotherapy and bevacizumab works better with or without PRI-724 in treating patients with metastatic colorectal cancer.

Key Dates

First listed
Apr 10, 2015
Start date
Nov 30, 2015
Status verified
Apr 2017
Primary completion
Nov 30, 2017
Completion
Nov 30, 2018

Study Design

Enrollment
0 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm I (PRI-724, mFOLFOX6/bevacizumab)
    Patients receive CBP/beta-catenin antagonist PRI-724 IV continuously on days 1-7, bevacizumab IV over 30 minutes, leucovorin calcium IV over 2 hours, oxaliplatin IV over 2 hours, and fluorouracil IV over 46 hours on day 8. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
  • Experimental: Arm II (mFOLFOX6/bevacizumab)
    Patients receive bevacizumab, leucovorin calcium, oxaliplatin, and fluorouracil as in Arm I. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Progression free survival (PFS) [ Time Frame: From time of randomization to time of progression or death on study whichever comes first, assessed up to 2 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
USC Norris Comprehensive Cancer CenterLos AngelesCalifornia90033-

Find similar trials in Los Angeles, CA

By research site
USC Norris Comprehensive Cancer Center· Los Angeles, CA

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