CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 17 enrolled
Drug / intervention
pertuzumab +8 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/NCT00551421
NCT00551421Phase 2Completed
CompareCT.gov

A Phase I/II Trial of Pertuzumab in Combination With Cetuximab and Irinotecan in Previously Treated Metastatic Colorectal Cancer

National Cancer Institute (NCI)·interventional·Posted Oct 31, 2007·Updated Mar 31, 2015

In Brief

A Phase 2 clinical trial evaluating pertuzumab, cetuximab, and 7 other interventions for Adenocarcinoma of the Colon and 7 related conditions. Completed, enrolled 17 participants across 1 site.

Detailed Summary

Monoclonal antibodies, such as pertuzumab and cetuximab, 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. Giving pertuzumab together with cetuximab may kill more tumor cells. This phase I/II trial is studying the side effects and best dose of pertuzumab when given together with cetuximab and to see how well they work in treating patients with previously treated locally advanced or metastatic colorectal cancer

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdenocarcinoma of the Colon, Adenocarcinoma of the Rectum, Recurrent Colon Cancer, Recurrent Rectal Cancer, Stage III Colon Cancer, Stage III Rectal Cancer, Stage IV Colon Cancer, Stage IV Rectal Cancer
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 31, 2007
Enrollment StartOct 1, 2007
Primary CompletionNov 1, 2010
Study CompletionJun 1, 2012
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 18.7 years ago

Interventions

pertuzumabbiological

Given IV

cetuximabbiological

Given IV

irinotecan hydrochloridedrug

Given IV

immunohistochemistry staining methodother

Correlative study

fluorescence in situ hybridizationother

Correlative study

gene expression analysisother

Correlative study

mutation analysisother

Correlative study

polymerase chain reactionother

Correlative study

laboratory biomarker analysisother

Correlative study