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Hepatic Arterial Infusion of Oxaliplatin, Fluorouracil, Leucovorin, and Avastin

NCT00507585 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2012-07-30

No results posted yet for this study

Summary

PRIMARY:

* To determine the toxicity and tolerability of intra-arterial hepatic oxaliplatin every three weeks administered in combination with systemic intravenous Fluorouracil, Leucovorin and bevacizumab to patients with advanced solid tumors metastatic to the liver.

SECONDARY:

* To document in a descriptive fashion the antitumor efficacy of this combination regimen.
* To evaluate the feasibility and accuracy of an alternate radiographic assessment tool and compare with available tumor markers and RECIST guidelines.
* To estimate in a descriptive fashion the development of extrahepatic tumor recurrences.

Conditions

Interventions

DRUG

Fluorouracil

300 mg/m\^2 IV over 10 Minutes, then 600 mg/m\^2 IV over 22 Hours repeated every 3 weeks (1 Cycle).

DRUG

Avastin

10 mg/m\^2 IV Over 90 Minutes repeated every 3 weeks (1 Cycle).

DRUG

Leucovorin

200 mg/m\^2 IV Over 2 Hours repeated every 3 weeks (1 Cycle).

DRUG

Oxaliplatin

60 mg/m\^2 IV Over 2 Hours repeated every 3 weeks (1 Cycle).

Sponsors & Collaborators

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Apostolia M. Tsimberidou, MD, PhD · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-06-30
Primary Completion
2010-01-31
Completion
2010-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT00507585 on ClinicalTrials.gov