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

Head and Neck Cancer Clinical Trial

Official title: 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

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms

• NCT number: NCT00203905
• Study type: Interventional
• Source: University of Chicago
• Status: Completed
• Phase: Phase 2
• Start date: January 2004
• Completion date: November 2008