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Azacitidine and CAPOX in Metastatic Colorectal Cancer

NCT01193517 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2020-04-15

Study results available
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Summary

The goal of the Phase I portion of this study is to find the highest tolerable dose of azacitidine combined with capecitabine and oxaliplatin (CAPOX) that can be given to patients with metastatic colorectal cancer.

The goal of the Phase II portion of this study is to learn if azacitidine, given in combination with CAPOX, can help to control metastatic colorectal cancer. The safety of this drug combination will also be studied.

Conditions

Interventions

DRUG

Azacitidine

Starting dose level 75 mg/m2/day subcutaneously on Days 1-5 of a 21 day cycle.

DRUG

Capecitabine

1500 mg/m2/day by mouth twice daily in divided doses on Days 1-14 of a 21 day cycle.

DRUG

Oxaliplatin

Starting dose level 90 mg/m2 by vein on Day 2 of a 21 day cycle.

DRUG

Azacitidine MTD

Highest tolerable dose of combination azacitidine with CAPOX found in Phase I.

Sponsors & Collaborators

  • Celgene

    collaborator INDUSTRY

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Michael Overman, MD · M.D. Anderson Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-08-31
Primary Completion
2016-11-30
Completion
2016-11-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT01193517 on ClinicalTrials.gov