CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 106 enrolled
Drug / intervention
cetuximab +2 morebiological
Likely dose
Not stated in 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/NCT02164916
NCT02164916Phase 2Completed

Randomized Phase II Study of Irinotecan and Cetuximab With or Without Vemurafenib in BRAF Mutant Metastatic Colorectal Cancer

SWOG Cancer Research Network·interventional·Posted Jun 17, 2014·Updated Dec 30, 2020

In Brief

A Phase 2 clinical trial evaluating cetuximab, irinotecan hydrochloride, and 1 other intervention for Colorectal Cancer. Completed, enrolled 106 participants across 763 sites.

Detailed Summary

This randomized phase II trial studies how well irinotecan hydrochloride and cetuximab with or without vemurafenib works in treating patients with colorectal cancer that has spread to nearby tissue or lymph nodes, that has spread to other places in the body, or cannot be removed by surgery. Irinotecan hydrochloride and vemurafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as cetuximab, may block the ability of tumor cells to grow and spread. It is not yet known whether irinotecan hydrochloride and cetuximab are more effective with or without vemurafenib in treating colorectal cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJun 17, 2014
Enrollment StartNov 1, 2014
Primary CompletionNov 13, 2017
Study CompletionNov 19, 2020
TodayJul 2, 2026
Enrollment to primary: 3.0 yearsPosted 12.0 years ago

Interventions

cetuximabbiological

Given IV

irinotecan hydrochloridedrug

Given IV

vemurafenibdrug

Given PO