NCT00023959|CompletedPhase 1

Bevacizumab, Fluorouracil, and Hydroxyurea Plus Radiation Therapy in Treating Patients With Advanced Head and Neck Cancer

A Phase I Study Of Bevacizumab (Recombinant Humanized Monoclonal Antibody To Vascular Endothelial Growth Factor) In Addition To Flourouracil And Hydroxyurea As Initial Chemotherapy With Concomitant Radiotherapy (B-FHX) For Poor Prognosis Head And Neck Cancer

National Cancer Institute (NCI)ClinicalTrials.gov

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3 other identifiers

NCI-2012-0240811033BCDR0000068879

Study Type

interventional

Target

Locations

1 country

Sites

Timeline

RegisteredJan 2003

StartedJul 2001

Brief Summary

Monoclonal antibodies, such as bevacizumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or deliver cancer-killing substances to them. Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining monoclonal antibody therapy with chemotherapy and radiation therapy may be an effective treatment for head and neck cancer. This phase I trial is to see if combining bevacizumab, fluorouracil, and hydroxyurea with radiation therapy works in treating patients who have advanced head and neck cancer

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P50-P75 for phase_1

Geographic Reach

1 country

1 active site

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2001

Completed

2 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2001

Completed

1.4 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed

7.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed

Last Updated

February 7, 2013

Status Verified

February 1, 2013

Enrollment Period

8.7 years

First QC Date

September 13, 2001

Last Update Submit

February 6, 2013

Conditions

Outcome Measures

Primary Outcomes (1)

MTD defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity assessed using NCI CTCAE version 3.0
14 weeks

Secondary Outcomes (5)

Objective response rate (CR+PR) assessed using RECIST criteria
Up to 9 years
Pattern of failure, described as locoregional, distant, or both
Up to 9 years
Duration of response
From the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented, assessed up to 9 years
Progression free survival
From the date of registration to the date of progressive disease or death, assessed up to 9 years
Overall survival
From the date of registration to the date of death, assessed up to 9 years

Study Arms (1)

Treatment (hydroxyurea, fluorouracil, bevacizumab, radiation)

EXPERIMENTAL

Patients receive oral hydroxyurea every 12 hours on days 1-6, fluorouracil IV continuously on days 1-5, and bevacizumab IV over 90 minutes on day 1. Patients also undergo radiotherapy once daily on days 1-5. Patients receive G-CSF subcutaneously on days 6-12. Treatment repeats every 2 weeks for up to 7 courses in the absence of disease progression or unacceptable toxicity.

Drug: hydroxyureaDrug: fluorouracilBiological: bevacizumabRadiation: radiation therapyBiological: filgrastimOther: laboratory biomarker analysis