CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 26 enrolled
Drug / intervention
Azacitidine +3 moredrug
Likely dose
Azacitidine 75 mg/m2from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01193517
NCT01193517Phase 2Completed
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Phase I/II Study of Azacitidine and CAPOX (Capecitabine + Oxaliplatin) in Metastatic Colorectal Cancer Patients Enriched for Hypermethylation of CpG Promoter Islands

M.D. Anderson Cancer Center·interventional·Posted Sep 2, 2010·Updated Apr 15, 2020

In Brief

A Phase 2 clinical trial evaluating Azacitidine, Capecitabine, and 2 other interventions for Colorectal Cancer. Completed, enrolled 26 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsColorectal Cancer
CountriesUnited States
CollaboratorsCelgene

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedSep 2, 2010
Enrollment StartAug 1, 2010
Primary CompletionNov 1, 2016
TodayJul 2, 2026
Enrollment to primary: 6.3 yearsPosted 15.8 years ago

Interventions

Azacitidinedrug

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

Capecitabinedrug

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

Oxaliplatindrug

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

Azacitidine MTDdrug

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