CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 66 enrolled
Drug / intervention
cetuximab +4 morebiological
Likely dose
FOLFOX6 (5-FU/leucovorin/oxaliplatin) plus bevacizumab and cetuximab IVAI-extracted
Key inclusion· 8
  • Histologically or cytologically confirmed adenocarcinoma of colon or rectum unresectable by surgery (stage IV)
  • Measurable disease
  • ECOG performance status ≤1
  • Life expectancy >3 months
Key exclusion· 13
  • Known brain metastases
  • Radiotherapy within 4 weeks prior to entry or incomplete recovery from prior radiotherapy
  • Concurrent investigational agents
  • History of allergic reactions to similar agents used in study

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

Search/NCT00100841
NCT00100841Phase 2Completed

Phase II Trial of FOLFOX6, Bevacizumab and Cetuximab in Patients With Colorectal Cancer

National Cancer Institute (NCI)·interventional·Posted Jan 7, 2005·Updated Jul 27, 2015

In Brief

A Phase 2 clinical trial evaluating cetuximab, bevacizumab, and 3 other interventions for Adenocarcinoma of the Rectum and 6 related conditions. Completed, enrolled 66 participants across 1 site.

Detailed Summary

Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab and cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of colorectal cancer by blocking blood flow to the tumor. Giving combination chemotherapy together with bevacizumab and cetuximab may kill more tumor cells. This phase II trial is studying how well giving combination chemotherapy together with bevacizumab and cetuximab works in treating patients with stage IV colorectal cancer that cannot be removed by surgery.

Study Details

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 7, 2005
Enrollment StartNov 1, 2004
Primary CompletionJul 1, 2011
TodayJul 2, 2026
Enrollment to primary: 6.7 yearsPosted 21.5 years ago

Interventions

cetuximabbiological

Given IV

bevacizumabbiological

Given IV

oxaliplatindrug

Given IV

leucovorin calciumdrug

Given IV

fluorouracildrug

Given IV