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

NCT02413853 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2017-04-17

No results posted yet for this study

Summary

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.

Conditions

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

Interventions

DRUG

CBP/beta-catenin Antagonist PRI-724

Given IV

BIOLOGICAL

Bevacizumab

Given IV

DRUG

Leucovorin Calcium

Given IV

DRUG

Oxaliplatin

Given IV

DRUG

Fluorouracil

Given IV

OTHER

Laboratory Biomarker Analysis

Correlative studies

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Prism Pharma Co., Ltd.

    collaborator INDUSTRY

  • University of Southern California

    lead OTHER

Principal Investigators

  • Heinz-Josef Lenz · University of Southern California

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2017-11-30
Completion
2018-11-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02413853 on ClinicalTrials.gov