CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 40 enrolled
Drug / intervention
Bevacizumab +2 moredrug
Likely dose
Bevacizumab 5 mg/kg IV every 2 weeks; Capecitabine 2500 mg/m2 orally daily (1250 mg/m2 twice daily) in 1 week on/1 week off cycles; Oxaliplatin 85 mg/m2 IV on day 1 of 2-week cycleAI-extracted
Key inclusion· 9
  • Advanced, surgically unresectable colorectal cancer
  • Measurable disease by imaging (at least one lesion accurately measurable in one dimension)
  • Histologically confirmed adenocarcinoma of colon or rectum
  • ECOG performance status 0, 1, or 2
Key exclusion· 10
  • Any systemic therapy for metastatic or locally recurrent disease
  • Candidate for surgical resection of metastatic/locally advanced disease
  • Non-adenocarcinoma histology of colon or rectum
  • Pregnancy or lactation; women of childbearing potential without pregnancy test

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

Search/NCT00177307
NCT00177307Phase 2Completed

Phase II Study of the A-ICOX Regimen Consisting of Bevacizumab (Avastinâ), Intermittent Dose Capecitabine (Xelodaâ) and Oxaliplatin (Eloxatinâ) in Patients With Untreated Advanced Colorectal Cancer

University of Pittsburgh·interventional·Posted Sep 15, 2005·Updated Jul 12, 2016

In Brief

A Phase 2 clinical trial evaluating Bevacizumab, Capecitabine, and 1 other intervention for Cancer. Completed, enrolled 40 participants across 1 site.

Detailed Summary

This is a Phase II study of the drug combination of Oxaliplatin, Avastin and capecitabine. This is an open-label study.

Study Details

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

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 15, 2005
Enrollment StartJan 1, 2005
Primary CompletionFeb 1, 2012
TodayJul 2, 2026
Enrollment to primary: 7.1 yearsPosted 20.8 years ago

Interventions

Bevacizumabdrug

Bevacizumab 5 mg/kg by 90-30 minute IV infusion IV q 2 weekly Until disease progression or unacceptable toxicity

Capecitabinedrug

Capecitabine will be administered orally at twice daily 1250 mg/m2 (equivalent to a total daily dose of 2500 mg/m2) as intermittent therapy (1 week of treatment followed by one week without treatment) and this cycle repeated every 14 days. The first dose of capecitabine will be given on day 1 of each cycle as evening dose and the last dose will be given on day 8 as morning dose (for a total of 14 single doses per cycle).

Oxaliplatindrug

Oxaliplatin will be administered at the dose of 85 mg/m2 given as a 2-hour intravenous infusion on day 1 of a two-week cycle, prior to the first dose of capecitabine