CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 63 enrolled
Drug / intervention
Oxaliplatin +2 moredrug
Likely dose
Not stated in record
Key inclusion· 5
  • Histologically or cytologically confirmed metastatic or recurrent colorectal cancer with no previous treatment for advanced disease
  • Age ≥18 years
  • SWOG performance status 0-1
  • At least one measurable lesion ≥10 mm on spiral CT or ≥20 mm on conventional imaging per RECIST criteria, not previously irradiated
Key exclusion· 21
  • Pregnant or lactating
  • Life expectancy <3 months
  • Prior oxaliplatin treatment, except adjuvant therapy given >12 months prior
  • Prior severe reaction or hypersensitivity to fluoropyrimidines, known 5-FU hypersensitivity, or DPD deficiency

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

Search/NCT00159432
NCT00159432Phase 2Completed

Phase II Study of Oxaliplatin, Capecitabine and Bevacizumab as First Line Treatment for Patients With Advanced Colorectal Cancer

University of Southern California·interventional·Posted Sep 12, 2005·Updated Jul 29, 2014

In Brief

A Phase 2 clinical trial evaluating Oxaliplatin, Bevacizumab, and 1 other intervention for Colorectal Cancer. Completed, enrolled 63 participants across 1 site.

Detailed Summary

This study is for people with colorectal cancer, who have tumors that cannot be completely removed by surgery. This study is being done to find out how long it takes tumors to grow after patients receive the drugs capecitabine, oxaliplatin and bevacizumab. Capecitabine (also called Xeloda) is a drug that has been approved by the FDA for treatment of advanced colorectal cancer. Capecitabine prevents some colorectal cancer cancer cells from reproducing, and causes some of them to die. Oxaliplatin (also called Eloxatin) has also been approved by the FDA for treatment of advanced colorectal cancer. Oxaliplatin prevents some colorectal cancer cells from reproducing. Bevacizumab is an investigational drug. Bevacizumab is an antibody (a protein that acts against a specific substance) directed against vascular endothelial growth factor (VEGF). VEGF promotes the growth of blood vessels that bring nutrients to cells. Bevacizumab inhibits the growth of colon cancer cells, by blocking the effects of VEGF. The combination of the drugs used in this study is experimental. The purpose of this study is to see how long it takes patients' tumors to grow when they are taking this combination of drugs.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 12, 2005
Enrollment StartFeb 1, 2005
Primary CompletionJun 1, 2009
Study CompletionMar 1, 2013
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 20.8 years ago

Interventions

Oxaliplatindrug

Bevacizumabdrug

Capecitabinedrug