A Study of Chemoradiotherapy for Intermediate Stage/Selected Stage IV Cancers of the Head and Neck

Part of paid clinical trials in Chicago, Illinois.

Sponsor
University of Chicago
Study ID
NCT00203905
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 5-Fluorouracil, Hydroxyurea-[FHX], Bevacizumab — DRUG
    Hydroxyurea at 500 mg PO q 12 hours x 6 days; Bevacizumab at 10 mg/kg as a 90-minute infusion; Infusion of 5-FU (600 mg/m2/day) X 5 days (120 hours)
  • 5-Fluorouracil, Hydroxyurea-[FHX] — DRUG
    Hydroxyurea at 500 mg PO q 12 hours x 6 days; Infusion of 5-FU (600 mg/m2/day) X 5 days (120 hours)

Study Details

The primary objective of the study is to evaluate time to progression in eligible patients with cancer of the oral cavity, pharynx, larynx, paranasal sinuses, and cervical esophagus when treated with the concomitant chemoradiotherapy regimen of bevacizumab/5-fluorouracil (5-FU)/hydroxyurea/radiation therapy (B-FHX) in comparison to 5-fluorouracil hydroxyurea (FHX) alone.

Key Dates

First listed
Sep 20, 2005
Start date
Jan 31, 2004
Status verified
Jan 2014
Primary completion
Nov 30, 2007
Completion
Nov 30, 2008

Study Design

Enrollment
23 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: A
    Hydroxyurea at 500 mg PO q 12 hours x 6 days (11 total doses); Infusion of 5-FU (600 mg/m2/day x 5 days \[120 hours\]
  • Experimental: B
    Bevacizumab: 10 mg/kg will be given as a 90-minute infusion

Primary Outcome Measure

To evaluate the time to progression free survival in patients with cancer of the oral cavity, pharynx, larynx, paranasal sinuses, and cervical esophagus when treated with the concomitant chemoradiotherapy regimen [ Time Frame: From randomization until disease progression or death from any cause ]

Locations (1)

FacilityCityStateZIPSite coordinators
The University of ChicagoChicagoIllinois60637-

Find similar trials in Chicago, IL

By condition
Head and neck cancer
By specialty
OncologyENT
By research site
The University of Chicago· Chicago, IL

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