CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 302 enrolled
Drug / intervention
UFOX + Cetuximab +1 moredrug
Likely dose
FOLFOX-4 + Cetuximab: Cetuximab 400 mg/m² on day 1 cycle 1, then 250 mg/m² weekly; Oxaliplatin 85 mg/m² on days 1 and 15 every 2 weeks; 5-FU 400 mg/m² bolus plus infusions on days 1, 2, 15, 16; Folinic acid 200 mg/m² OR UFOX + Cetuximab: Cetuximab 400 mg/m² on day 1 cycle 1, then 250 mg/m² weekly; Oxaliplatin 85 mg/m² on days 1 and 15 every 2 weeks; Oral UFT 250 mg/m² tegafur + 560 mg/m² uracil in 3 daily dosesAI-extracted
Key inclusion· 9
  • ✓Histologically confirmed adenocarcinoma of colon or rectum with metastatic disease (first occurrence, not curatively resectable)
  • ✓At least one measurable lesion by CT or MRI (not in previously irradiated area)
  • ✓Age ≥18 years
  • ✓Life expectancy ≥3 months
Key exclusion· 10
  • ✕Brain metastasis and/or leptomeningeal disease (known or suspected)
  • ✕Prior chemotherapy for colorectal cancer, except adjuvant therapy completed >6 months prior without progression
  • ✕Prior oxaliplatin-based chemotherapy
  • ✕Surgery or irradiation within 4 weeks prior to randomization

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

Search/NCT00439517
NCT00439517Phase 2Completed
CompareCT.gov

A Randomized, Open-label Phase II Study Evaluating the Efficacy and Safety of FOLFOX-4 Plus Cetuximab Versus UFOX Plus Cetuximab as First-line Therapy in Subjects With Metastatic Colorectal Cancer.

Merck KGaA, Darmstadt, Germany·interventional·Posted Feb 23, 2007·Updated Jun 27, 2014

In Brief

A Phase 2 clinical trial evaluating UFOX + Cetuximab and FOLFOX4 + Cetuximab for Previously Untreated Metastatic Colorectal Cancer. Completed, enrolled 302 participants across 57 sites in 14 countries.

Detailed Summary

This is an exploratory study to compare activity and safety in 400 patients with previously untreated metastatic carcinoma of the colon treated with UFOX (a combination regimen of UFT® (Tegafur plus Uracil), Oxaliplatin, Folinic Acid) plus Cetuximab or FOLFOX-4 (a combination regimen of 5 Fluorouracil (5-FU), Oxaliplatin and Folinic Acid) plus Cetuximab)

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPreviously Untreated Metastatic Colorectal Cancer
CountriesArgentina, Australia, Austria, Belgium, Brazil, France, Germany, Greece, Hong Kong, Israel, Italy, Mexico, Poland, Thailand
Collaborators--

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 23, 2007
Enrollment StartFeb 1, 2007
Primary CompletionJun 1, 2009
Study CompletionMay 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 19.4 years ago

Interventions

UFOX + Cetuximabdrug

* Cetuximab infusion (400 mg/m\^2 on day 1 of cycle 1 and 250 mg/m\^2 at each subsequent day 1, as well as on days 8, 15 and 22) * Oxaliplatin infusion (85mg/m\^2) on days 1 and 15 (every 2 weeks) * Oral UFT® (250mg/m\^2 tegafur + 560 mg/m\^2 uracil in 3 daily doses rounded to the nearest number of whole capsules) on days 1-21 * Oral Folinic Acid (90 mg in 3 daily divided doses) on days 1-21

FOLFOX4 + Cetuximabdrug

* Cetuximab infusion (400 mg/m\^2 on day 1 of cycle 1 and 250 mg/m\^2 at each subsequent day 1, as well as on days 8, 15 and 22) * Oxaliplatin infusion (85 mg/m\^2) on days 1 and 15 (every 2 weeks) * 5-FU bolus + infusions (400 mg/m\^2) on days 1, 2, 15 and 16 * Folinic Acid infusions (200 mg/m\^2) on days 1, 2, 15 and 16