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Phase I Vandetanib Plus Capecitabine, Oxaliplatin and Bevacizumab for Metastatic Colorectal Cancer

NCT00532909 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2012-07-16

No results posted yet for this study

Summary

To determine the maximum tolerated dose of Vandetanib with a current standard first-line chemotherapy regimen, capecitabine and oxaliplatin without and then with bevacizumab for the first line treatment of metastatic colorectal cancer (CRC) and to define the dose limiting toxicities associated with the combination.

Conditions

  • Anal, Colon, and Rectal Cancers
  • Colorectal Neoplasms
  • Colon/Rectal Cancer

Interventions

DRUG

Vandetanib

100mg or 300mg By mouth every day continuous

DRUG

Capecitabine

Dosage: 1000mg/m2 By mouth twice a day for 14 days or reduced dose of 800mg/m2 PO BID days1-14.

DRUG

Oxaliplatin

dosage: 130mg/m2. IV Day 1 of a 21 day cycle or reduced dose of 100mg/m2 IV Day 1.

DRUG

Bevacizumab

Dosage: 7.5mg/kg or 10mg/kg. IV Day 1 (21 day cycle)

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • Branimir Sikic

    lead OTHER

Principal Investigators

  • Branimir I Sikic · Stanford University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-07-31
Primary Completion
2010-05-31
Completion
2010-05-31

Countries

  • United States

Study Locations

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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 NCT00532909 on ClinicalTrials.gov