A Randomized Phase II Study of Concomitant Chemoradiotherapy With 5-Fluorouracil/Hydroxyurea Compared to FHX Plus Bevacizumab for Intermediate Stage and Selected Stage IV Cancers of the Head and Neck
In this study, we intend to explore the feasibility and the effects of adding bevacizumab to
Fl-TX in patients with intermediate stage head and neck cancer and selected patients with
stage IV disease. As mentioned previously, although single modality therapy (surgery or
radiotherapy alone) is often used to treat patients with Stage II head and neck
malignancies, with substantial success, still there is a sizeable group of patients
(approximately 30% or 40%) who fail these treatments, and represent with locoregional
recurrences which are much more difficult to treat. Furthermore, the common use of radical
surgery in many instances leads to loss of organ function.
Based on this knowledge, we feel that it is justifiable to include stage II patients (T2NO)
in combined chemoradiation studies. Our extensive experience using chemoradiotherapy in
patients with regionally advanced non-metastatic Stage 4 cancers of the head and neck area
suggests that selected patients with low nodal status (Nondisease) including those with T4
primaries (i.e. T4 NO MO and T4 Nl MO) have a lower risk of distant failure than patients
that present with higher nodal status (N2 and N3 disease). Aggressive combined locoregional
therapies such as the one that will be administered in the study, are in our opinion
appropriate for this group of patients as they address the major concern which is
locoregional failure.
The primary goal of the study is exploration of the pharmacodynamic effects of bevacizumab
(10 mg/kg) on appropriate markers of angiogenesis in tumor tissue in comparison to a
non-bevacizumab containing chemoradiation regimen (FHX alone). These results will be
correlated with a number of clinical endpoints including rapidity of clinical response,
locoregional control rates, time to progression, need of salvage surgery, overall survival
and measures of QOL and organ function. The predictive and prognostic value of specific
molecular markers in patients with HNC will also be evaluated. In order to shorten the total
duration of treatment without affecting the total administered dose, we have modified our
traditional radiation schedule in FHX to include two treatment daily fractions as opposed to
one. This modification will allow for the completion of all treatment in 4 to 5 cycles as
opposed to the traditional 6 to 7 cycles. Given this modification in the radiation schedule,
we considered it prudent to include a control arm (modified FHX) in addition to B-FHX,
within a randomized design. The control arm will also help with the interpretation of the
results obtained with the measurement of the correlative markers of angiogenesis.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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
From randomization until disease progression or death from any cause
Yes
Everett Vokes, M.D.
Principal Investigator
University of Chicago
United States: Food and Drug Administration
12652A
NCT00203905
January 2004
November 2008
Name | Location |
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The University of Chicago | Chicago, Illinois 60637 |