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Capecitabine and 131I-huA33 in Patients With Metastatic Colorectal Cancer

NCT00291486 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2022-10-10

Study results available
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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).

Conditions

  • Colorectal Neoplasms

Interventions

DRUG

Capecitabine

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.

DRUG

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

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).

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Ludwig Institute for Cancer Research

    lead OTHER

Principal Investigators

  • Prof. Andrew M Scott, MBBS, DDU MD · Ludwig Institute for Cancer Research

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-10-31
Primary Completion
2008-01-03
Completion
2012-08-29
FDA Drug
Yes

Countries

  • Australia

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00291486 on ClinicalTrials.gov