CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,183 enrolled
Drug / intervention
Panitumumab +1 moredrug
Likely dose
Panitumumab 6 mg/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/NCT00364013
NCT00364013Phase 3Completed

A Randomized, Multicenter, Phase 3 Study to Compare the Efficacy of Panitumumab in Combination With Oxaliplatin/ 5-fluorouracil/ Leucovorin to the Efficacy of Oxaliplatin/ 5-fluorouracil/ Leucovorin Alone in Patients With Previously Untreated Metastatic Colorectal Cancer

Amgen·interventional·Posted Aug 15, 2006·Updated Nov 7, 2022

In Brief

A Phase 3 clinical trial evaluating Panitumumab and FOLFOX regimen for Metastatic Colorectal Cancer. Completed, enrolled 1,183 participants.

Detailed Summary

The purpose of this study is to determine the treatment effect of panitumumab in combination with FOLFOX compared to FOLFOX alone as first line therapy for metastatic colorectal cancer

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
Countries--
Collaborators--

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 15, 2006
Enrollment StartAug 1, 2006
Primary CompletionAug 1, 2009
Study CompletionMar 22, 2013
TodayJul 2, 2026
Enrollment to primary: 3 yearsPosted 19.9 years ago

Interventions

Panitumumabdrug

Panitumumab 6 mg/kg over on Day 1 of each 14-day cycle, just prior to the administration of chemotherapy.

FOLFOX regimendrug

The FOLFOX regimen consisted of oxaliplatin 85 mg/m\^2 intravenous (IV) infusion on Day 1, leucovorin, 200 mg/m\^2 (racemate) on Days 1 and 2 and 5-fluorouracil 400 mg/m\^2 IV bolus followed by 600 mg/m\^2 IV infusion over 22 hours on Days 1 and 2. Each cycle was 14 days.