At a glance

ClinicalIndex Comparison Record

Phase 1Completed· 36 enrolled

Drug / intervention

Avastin +2 moredrug

Likely dose

Avastin 7.5mg/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/NCT00353262

NCT00353262Phase 1Completed

Compare CT.gov

An Open-label Study to Assess the Pharmacokinetic Interaction Between Xeloda and Oxaliplatin in Patients With Metastatic Colorectal Cancer.

Hoffmann-La Roche·interventional·Posted Jul 18, 2006·Updated Mar 4, 2016

In Brief

A Phase 1 clinical trial evaluating Avastin, Oxaliplatin, and 1 other intervention for Colorectal Cancer. Completed, enrolled 36 participants across 3 sites.

Detailed Summary

This single arm study will investigate possible pharmacokinetic interactions between Xeloda and oxaliplatin, and assess whether the pharmacokinetics of Xeloda and/or oxaliplatin is influenced by the addition of Avastin. All subjects will provide samples for pharmacokinetic analysis during the first 3 cycles of treatment. In cycles 1 and 2 patients will receive a treatment regimen containing Xeloda (1000mg/m2 bid) and oxaliplatin (130mg/m2 iv) and in cycle 3 Avastin (7.5mg/kg iv) will be added to the regimen. The anticipated time on study treatment is 3-12 months, and the target sample size is \<100 individuals.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsColorectal Cancer

CountriesCanada

Collaborators--

Timeline

Phase 1CompletedFinished

20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartJul 2005

First PostedJul 2006

Primary CompletionSep 2006

Study CompletionApr 2008

TodayJul 2026

First PostedJul 18, 2006

Enrollment StartJul 1, 2005

Primary CompletionSep 1, 2006

Study CompletionApr 1, 2008

TodayJul 2, 2026

Enrollment to primary: 1.2 yearsPosted 20.0 years ago

Interventions

Avastindrug

7.5mg/kg iv (cycle 3 only)

Oxaliplatindrug

130mg/m2 iv (cycles 1, 2 and 3)

capecitabine [Xeloda]drug

1000mg/m2 po bid (cycles 1, 2 and 3)