CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 36 enrolled
Drug / intervention
Bevacizumab +4 moredrug
Likely dose
Modified FOLFOX6: 5-FU 400 mg/m² bolus then 2400 mg/m² continuous infusion over 46 hours; Leucovorin 350 mg IV; Oxaliplatin 85 mg/m² IV; Bevacizumab 5 mg/kg IV; Cetuximab 400 mg/m² day 1 cycle 1, then 250 mg/m² on days 1 and 8 of subsequent cyclesAI-extracted
Key inclusion· 8
  • ✓Metastatic colorectal cancer confirmed by biopsy
  • ✓Age 18 or older
  • ✓Evidence of disease progression at study entry
  • ✓At least one prior adjuvant chemotherapy regimen completed
Key exclusion· 10
  • ✕Any prior regimen for metastatic disease
  • ✕Prior EGFR inhibitor treatment
  • ✕Prior anti-angiogenic agent treatment
  • ✕Brain or nervous system metastases

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

Search/NCT00193219
NCT00193219Phase 2Completed
CompareCT.gov

A Randomized Phase II Study of Modified FOLFOX6 (Infusional 5-Fluorouracil/Leucovorin, Oxaliplatin) and Bevacizumab With or Without Cetuximab in Patients With Metastatic Colorectal Cancer

SCRI Development Innovations, LLC·interventional·Posted Sep 19, 2005·Updated Jan 11, 2022

In Brief

A Phase 2 clinical trial evaluating Bevacizumab, Cetuximab, and 3 other interventions for Colon Cancer. Completed, enrolled 36 participants across 10 sites.

Detailed Summary

This trial will evaluate the combination of modified infusional 5-fluorouracil/ leucovorin, oxaliplatin (FOLFOX6), bevacizumab, and cetuximab in patients with metastatic colorectal cancer. FOLFOX6 has proven to be a safe and effective regimen in first line treatment of advanced colorectal cancer. The role of epidermal growth factor (EGFR) inhibitors in an earlier treatment setting in combination with optimal chemotherapy regimens is an important emerging question.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsColon Cancer
CountriesUnited States
CollaboratorsBristol-Myers Squibb

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 19, 2005
Enrollment StartJul 1, 2005
Primary CompletionJun 1, 2008
Study CompletionJul 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 20.8 years ago

Interventions

Bevacizumabdrug

5 mg/kg IV

Cetuximabdrug

400 mg/m2 (first cycle only) IV on day 1 and 250 mg/m2 IV on day 8 with all subsequent cycles 250 mg/m2 IV on days 1 and 8

5-fluorouracildrug

400 mg/m2 bolus IV bolus followed by 2400 mg/m2 administered as continuous IV infusion over 46 hours via pump (outpatient)

Leucovorindrug

350 mg IV

Oxaliplatindrug

85 mg/m2 IV