CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 136 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/NCT01079780
NCT01079780Phase 2Completed

A Randomized Phase II Study of Irinotecan and Cetuximab With or Without the Anti-Angiogenic Antibody, Ramucirumab (IMC-1121B), in Advanced, K-ras Wild-Type Colorectal Cancer Following Progression on Bevacizumab-Containing Chemotherapy

Eastern Cooperative Oncology Group·interventional·Posted Mar 3, 2010·Updated Jun 28, 2023

In Brief

A Phase 2 clinical trial evaluating cetuximab, ramucirumab, and 1 other intervention for Colorectal Cancer. Completed, enrolled 136 participants across 255 sites.

Detailed Summary

RATIONALE: Drugs used in chemotherapy, such as irinotecan hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab and ramucirumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Cetuximab and ramucirumab may also stop the growth of colorectal cancer by blocking blood flow to the tumor. It is not yet know whether giving cetuximab and irinotecan hydrochloride together is more effective with or without ramucirumab in treating colorectal cancer. PURPOSE: This randomized phase II trial is studying the side effects and how well giving cetuximab and irinotecan hydrochloride with or without ramucirumab work in treating patients with advanced colorectal cancer with progressive disease after treatment with bevacizumab-containing chemotherapy.

Study Details

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

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 3, 2010
Enrollment StartJan 18, 2011
Primary CompletionFeb 22, 2021
Study CompletionAug 17, 2021
TodayJul 2, 2026
Enrollment to primary: 10.1 yearsPosted 16.3 years ago

Interventions

cetuximabbiological

Given IV

ramucirumabbiological

Given IV

irinotecan hydrochloridedrug

Given IV