CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 45 enrolled
Drug / intervention
Capecitabine (Xeloda) +1 moredrug
Likely dose
Capecitabine 1000 mg/m² orally twice daily for 2 weeks, followed by 1 week rest; Bevacizumab 7.5 mg/kg IV every 3 weeksAI-extracted
Key inclusion· 5
  • ✓Histologically or cytologically confirmed adenocarcinoma of the colon at initial diagnosis
  • ✓Stage IV disease with at least one measurable lesion by RECIST criteria
  • ✓ECOG performance status 2 (frail patients)
  • ✓No prior chemotherapy for metastatic disease (prior adjuvant chemotherapy permitted)
Key exclusion· 10
  • ✕Prior chemotherapy for metastatic colorectal cancer
  • ✕Prior treatment with any anti-angiogenic agent
  • ✕Current or prior history of CNS or brain metastases
  • ✕Neuropathy >grade 2 (NCI-CTC v3.0) at baseline

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

Search/NCT00203411
NCT00203411Phase 2Completed
CompareCT.gov

A Phase II Trial to Evaluate the Efficacy and Safety of Bevacizumab in Combination With Capecitabine (Xeloda) in Frail Patients With Untreated Metastatic Colorectal Cancer

Translational Oncology Research International·interventional·Posted Sep 20, 2005·Updated Feb 6, 2017

In Brief

A Phase 2 clinical trial evaluating Capecitabine (Xeloda) and Bevacizumab for Colorectal Cancer. Completed, enrolled 45 participants across 12 sites.

Detailed Summary

The purpose of this study is to evaluate the safety and effectiveness of the bevacizumab and capecitabine combination in frail patients with untreated metastatic colorectal cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsColorectal Cancer
CountriesUnited States
CollaboratorsGenentech, Inc.

Timeline

Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 20, 2005
Enrollment StartMar 1, 2006
Primary CompletionMar 1, 2011
TodayJul 2, 2026
Enrollment to primary: 5 yearsPosted 20.8 years ago

Interventions

Capecitabine (Xeloda)drug

1000mg/m\^2 administered orally twice daily for two weeks followed by one week rest period

Bevacizumabdrug

7.5 mg/kg IV will be administered every 3 weeks