CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 19 enrolled
Drug / intervention
Capecitabine +1 moredrug
Likely dose
Capecitabine 1500 mg/m2from 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/NCT00291486
NCT00291486Phase 1Completed
CompareCT.gov

Phase I Trial of Oral Capecitabine Combined With 131I-huA33 in Patients With Metastatic Colorectal Cancer

Ludwig Institute for Cancer Research·interventional·Posted Feb 14, 2006·Updated Oct 10, 2022

In Brief

A Phase 1 clinical trial evaluating Capecitabine and 131I-huA33 (131-Iodine on humanised monoclonal antibody A33) for Colorectal Neoplasms. Completed, enrolled 19 participants across 1 site.

Detailed Summary

The purpose of this clinical trial is to determine whether it is safe to treat patients with advanced colorectal cancer, with humanised A33 antibody tagged with radioactive iodine (131I-huA33) in combination with chemotherapy (capecitabine).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsColorectal Neoplasms
CountriesAustralia
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 1CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 14, 2006
Enrollment StartOct 1, 2003
Primary CompletionJan 3, 2008
Study CompletionAug 29, 2012
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 20.4 years ago

Interventions

Capecitabinedrug

Capecitabine was administered orally at doses between 1000 and 1500 mg/m2/day depending on assigned dose level for 14 days per 21-day cycle. Daily doses were rounded to the nearest 150 mg.

131I-huA33 (131-Iodine on humanised monoclonal antibody A33)drug

All patients received a dose of 5 mg huA33 conjugated to 5-8 mCi 131I. The therapy dose of 131I-huA33 comprised a constant protein dose of 10 mg/m2 huA33 regardless of dose level. The 131I-huA33 therapy dose was determined by the assigned dose level (i.e. 20, 30 or 40 mCi/m2 131I).