CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 2,035 enrolled
Drug / intervention
Oxaliplatin 130 mg/m^2 +8 moredrug
Likely dose
XELOX: Capecitabine 1000 mg/m² twice daily + Oxaliplatin 130 mg/m² IV every 3 weeks, with or without Bevacizumab 7.5 mg/kg IV every 3 weeksAI-extracted
Key inclusion· 3
  • ✓Adults ≥18 years of age
  • ✓Metastatic colorectal cancer
  • ✓At least 1 measurable target lesion
Key exclusion· 3
  • ✕Prior oxaliplatin or bevacizumab therapy
  • ✕Prior systemic chemotherapy or immunotherapy for advanced/metastatic disease
  • ✕Progressive disease during or within 6 months of completion of previous adjuvant therapy

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

Search/NCT00069095
NCT00069095Phase 3Completed
CompareCT.gov

A 2x2 Factorial Randomized Phase III Study of Intermittent Oral Capecitabine in Combination With Intravenous Oxaliplatin (Q3W) ("XELOX") With/Without Intravenous Bevacizumab (Q3W) Versus Bolus and Continuous Infusion Fluorouracil/Intravenous Leucovorin With Intravenous Oxaliplatin (Q2W) ("FOLFOX-4") With/Without Intravenous Bevacizumab (Q2W) as First-line Treatment for Patients With Metastatic Colorectal Cancer

Hoffmann-La Roche·interventional·Posted Sep 18, 2003·Updated Oct 6, 2016

In Brief

A Phase 3 clinical trial evaluating Oxaliplatin 130 mg/m^2, Capecitabine 1000 mg/m^2, and 7 other interventions for Colorectal Cancer. Completed, enrolled 2,035 participants across 236 sites in 33 countries.

Detailed Summary

This 4 arm study assessed the efficacy and safety of oral capecitabine (Xeloda) or intravenous (iv) fluorouracil/leucovorin, in combination with iv oxaliplatin (Eloxatin) with or without iv bevacizumab (Avastin), as a first-line treatment in patients with metastatic colorectal cancer. Patients were randomized to receive 1) XELOX (Xeloda 1000 mg/m\^2 orally \[po\] twice a day \[bid\] on Days 1-15 + oxaliplatin in 3 week cycles), 2) FOLFOX-4 (oxaliplatin + leucovorin + fluorouracil \[5-FU\] in 2 week cycles), 3) XELOX + bevacizumab (7.5 mg iv on Day 1 in 3 week cycles), or 4) FOLFOX-4 + bevacizumab (5 mg iv on Day 1 in 2 week cycles).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsColorectal Cancer
CountriesAustralia, Austria, Brazil, Canada, China, Czechia, Denmark, Finland, France, Germany, Guatemala, Hong Kong, Hungary, Ireland, Israel, Italy, Mexico, New Zealand, Norway, Panama, Portugal, Puerto Rico, Russia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey (Türkiye), United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 18, 2003
Enrollment StartJul 1, 2003
Primary CompletionJan 1, 2006
Study CompletionApr 1, 2009
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 22.8 years ago

Interventions

Oxaliplatin 130 mg/m^2drug

Oxaliplatin was administered in a 2 h infusion before the first dose of capecitabine.

Capecitabine 1000 mg/m^2drug

Capecitabine was taken within 30 min after the end of breakfast and dinner.

Bevacizumab 7.5 mg/kgdrug

Bevacizumab was administered in a 30 to 90 min infusion.

Placebo for bevacizumab 7.5 mg/kgdrug

Placebo control for bevacizumab (volume equivalent to 7.5 mg/kg bevacizumab) was administered in a 30 to 90 min infusion.

Oxaliplatin 85 mg/m^2drug

Oxaliplatin 85 mg/m\^2 was administered simultaneously with leucovorin in a 2 h infusion.

Leucovorin 200 mg/m^2drug

Leucovorin was administered simultaneously with oxaliplatin 85 mg/m\^2 in a 2 h infusion.

Fluorouracil 400 mg/m^2drug

Bevacizumab 5 mg/kgdrug

Bevacizumab was administered in a 30 to 90 min infusion.

Placebo for bevacizumab 5 mg/kgdrug

Placebo control for bevacizumab (volume equivalent to 5 mg/kg bevacizumab) was administered in a 30 to 90 min infusion.