CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,186 enrolled
Drug / intervention
Panitumumab +1 moredrug
Likely dose
FOLFIRI 180 mgfrom 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/NCT00339183
NCT00339183Phase 3Completed
CompareCT.gov

A Randomized, Multicenter Phase 3 Study to Compare the Efficacy of Panitumumab in Combination With Chemotherapy to the Efficacy of Chemotherapy Alone in Patients With Previously Treated Metastatic Colorectal Cancer

Amgen·interventional·Posted Jun 20, 2006·Updated Sep 23, 2022

In Brief

A Phase 3 clinical trial evaluating Panitumumab and FOLFIRI for Metastatic Colorectal Cancer. Completed, enrolled 1,186 participants.

Detailed Summary

The purpose of this study is to evaluate the treatment effect of panitumumab plus FOLFIRI compared to FOLFIRI alone as second line therapy for metastatic colorectal cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMetastatic Colorectal Cancer
Countries--
Collaborators--

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 20, 2006
Enrollment StartJun 30, 2006
Primary CompletionApr 1, 2009
Study CompletionNov 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 20.0 years ago

Interventions

Panitumumabdrug

Panitumumab was administered by IV infusion on Day 1 of each 14-day cycle, just before administration of FOLFIRI chemotherapy.

FOLFIRIdrug

FOLFIRI chemotherapy was initiated on Day 1 of each treatment cycle at the following starting doses: irinotecan 180 mg/m\^2, leucovorin 400 mg/m\^2 racemate (or 200 mg/m\^2 I-leucovorin), 5-FU bolus 400 mg/m\^2, 5-FU infusion 2400 mg/m\^2.