CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 43 enrolled
Drug / intervention
Irinotecan +3 moredrug
Likely dose
Panitumumab 2.5 mg/kg IV once weekly in 6-week cycles, in combination with irinotecan (Part 1: 125 mg/m² weekly weeks 1-4; Part 2: 180 mg/m² every other week), 5-FU (Part 1: 500 mg/m² IV bolus weeks 1-4; Part 2: 400 mg/m² bolus + 2400-3000 mg/m² infusion every other week), and leucovorin (Part 1: 20 mg/m² weeks 1-4; Part 2: 400 mg/m² every other week)AI-extracted
Key inclusion· 7
  • ✓Pathologically confirmed metastatic colorectal adenocarcinoma
  • ✓Unidimensionally measurable disease
  • ✓Tumor overexpressing EGFr by immunohistochemistry (≥10% of tumor cells with 1+, 2+, or 3+ staining)
  • ✓Paraffin-embedded tumor tissue available for EGFr immunohistochemistry studies (archived tissue acceptable)
Key exclusion· 14
  • ✕Untreated brain metastases
  • ✕Prior treatment for metastatic colorectal cancer
  • ✕Prior irinotecan
  • ✕Prior or concurrent radiation therapy for colorectal cancer, including adjuvant pelvic radiation

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00111761
NCT00111761Phase 2Completed
CompareCT.gov

A Clinical Trial of the Safety and Efficacy of ABX-EGF in Combination With Irinotecan, Leucovorin, and 5-Fluorouracil in Subjects With Metastatic Colorectal Cancer

Amgen·interventional·Posted May 26, 2005·Updated Dec 12, 2013

In Brief

A Phase 2 clinical trial evaluating Irinotecan, Panitumumab, and 2 other interventions for Colorectal Cancer. Completed, enrolled 43 participants.

Detailed Summary

The purpose of this study is to determine if panitumumab, in combination with irinotecan, leucovorin, and 5-fluorouracil (5-FU) is safe and efficacious in patients with metastatic colorectal cancer.

Study Details

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

Timeline

Phase 2CompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 26, 2005
Enrollment StartJul 1, 2002
Primary CompletionFeb 1, 2008
Study CompletionOct 1, 2008
TodayJul 2, 2026
Enrollment to primary: 5.6 yearsPosted 21.1 years ago

Interventions

Irinotecandrug

Part 1: 125 mg/m\^2 IV infusion once a week on weeks 1 through 4 of each 6-week treatment cycle. Part 2: 180 mg/m\^2 IV infusion every other week until disease progression or unable to tolerate.

Panitumumabbiological

Intravenous (IV) infusions of panitumumab 2.5 mg/kg once a week delivered in 6-week cycles.

5-Fluorouracildrug

Part 1: IV bolus 500 mg/m\^2 on weeks 1 through 4 of each 6-week cycle. Part 2: IV bolus 400 mg/m\^2 and infusional 2400-3000 mg/m\^2 over 46 hours once every other week until disease progression or unable to tolerate.

Leucovorindrug

Part 1: IV bolus 20 mg/m\^2 on weeks 1 through 4 of each 6-week cycle. Part 2: 400 mg/m\^2 every other week until disease progression or unable to tolerate.