CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 28 enrolled
Drug / intervention
panitumumab +2 morebiological
Likely dose
panitumumab 6mg/kgfrom 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/NCT00940316
NCT00940316Phase 2Completed

A Randomized Phase II Study of Dual Epidermal Growth Factor Receptor Inhibition With Erlotinib and Panitumumab With or Without Irinotecan as Second Line Therapy in Patients With Metastatic Colorectal Cancer

Northwestern University·interventional·Posted Jul 16, 2009·Updated May 7, 2019

In Brief

A Phase 2 clinical trial evaluating panitumumab, erlotinib hydrochloride, and 1 other intervention for Colorectal Cancer. Completed, enrolled 28 participants across 10 sites.

Detailed Summary

RATIONALE: Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as panitumumab, 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. Panitumumab may also stop the growth of colorectal cancer by blocking blood flow to the tumor. 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. It is not yet known whether erlotinib hydrochloride given together with panitumumab is more effective with or without irinotecan in treating patients with metastatic colorectal cancer. PURPOSE: This randomized phase II trial is studying giving erlotinib hydrochloride together with panitumumab to see how well it works with or without irinotecan hydrochloride as second-line therapy in treating patients with metastatic colorectal cancer.

Study Details

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

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJul 16, 2009
Enrollment StartJan 18, 2010
Primary CompletionJan 1, 2015
TodayJul 2, 2026
Enrollment to primary: 5.0 yearsPosted 17.0 years ago

Interventions

panitumumabbiological

Given intravenously 6mg/kg every 2 weeks

erlotinib hydrochloridedrug

Given orally 150mg daily

irinotecan hydrochloridedrug

Given intravenously 120mg/m2 for 6/6 genotype and 60mg/m2 for 6/7 genotype