CI

At a glance

ClinicalIndex Comparison Record
Phase 2Terminated· 7 enrolled
Drug / intervention
Bevacizumab +3 moredrug
Likely dose
Bevacizumab 7.5 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT00314353
NCT00314353Phase 2Terminated
Terminated

Randomized Phase II Clinical Trial of Bevacizumab Combined With Capecitabine and Either Oxaliplatin or Irinotecan as First Line Treatment for Metastatic Colorectal Cancer

NSABP Foundation Inc·interventional·Posted Apr 13, 2006·Updated Oct 6, 2021

In Brief

A Phase 2 clinical trial evaluating Bevacizumab, Oxaliplatin, and 2 other interventions for Colorectal Neoplasms. Terminated early, enrolled 7 participants across 1 site.

Signals

Trial was terminated early

Detailed Summary

Bevacizumab is an angiogenesis inhibitor which means it works to stop blood vessel formation in tumors. Without new blood vessels, the growth of a tumor is slowed. Chemotherapy works to kill cancer cells directly. This study is being done to see how colorectal cancer responds to treatment with the combination of bevacizumab and chemotherapy.

Study Details

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

Timeline

Phase 2TerminatedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 13, 2006
Enrollment StartMar 1, 2006
Primary CompletionMay 1, 2008
Study CompletionJun 1, 2010
TodayJul 1, 2026
Enrollment to primary: 2.2 yearsPosted 20.2 years ago

Interventions

Bevacizumabdrug

7.5 mg/kg IV Day 1 every 21 days for eight cycles\* \*For patients with stable or responding disease after 8 cycles, continue bevacizumab at the same dose levels until disease progression.

Oxaliplatindrug

130 mg/m2 IV Day 1 every 21 days for eight cycles

Capecitabinedrug

850 mg/m2 po BID Days 1-14 every 21 days for eight cycles\*# \*For patients with stable or responding disease after 8 cycles, continue capecitabine at the same dose levels until disease progression. #For patients with baseline calculated creatinine clearance of 30-50 mL/min, the starting dose will be reduced to 650 mg/m2 BID

Irinotecandrug

200 mg/m2 IV Day 1 every 21 days for eight cycles