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Combination of Cetuximab, Capecitabine, and Oxaliplatin With or Without Bevacizumab

NCT00321100 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2022-01-12

Study results available
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Summary

The purpose of this study is to determine the objective response rate of patients with previously untreated metastatic colorectal cancer treated with the combination of cetuximab, capecitabine, and oxaliplatin with out without bevacizumab.

Conditions

  • Colorectal Neoplasms

Interventions

DRUG

bevacizumab

Bevacizumab 7.5mg/kg IV day 1 of each 21 day cycle

DRUG

cetuximab

Cetuximab 400mg/m2 IV initial dose (cycle 1 day 1 only), then 250mg/m2 IV weekly each 21 day cycle

DRUG

Oxaliplatin

Oxaliplatin 130mg/m2 IV day 1 every 21 days

DRUG

Capecitabine

Capecitabine 850mg/m2 PO every 12 hours days 1-14 of each 21 day cycle

Sponsors & Collaborators

  • Fox Chase Cancer Center

    lead OTHER

Principal Investigators

  • Steven Cohen, MD · Fox Chase Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-04-12
Primary Completion
2009-04-30
Completion
2013-12-18

Countries

  • United States

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 NCT00321100 on ClinicalTrials.gov