At a glance
ClinicalIndex Comparison Record- ✓Locally advanced squamous carcinoma of head and neck (AJCC stages II-IV, M0), excluding T1N1 and T1N2, undergoing curative-intent concurrent chemoradiation
- ✓Eligible primary tumor sites: oral cavity, oropharynx, hypopharynx, supraglottic, or glottic larynx
- ✓No prior treatment except diagnostic biopsy
- ✓Karnofsky Performance Status >60
- ✕Nasopharyngeal primary site
- ✕History of malignancy other than basal cell skin cancer
- ✕History of claudication, bleeding, or thromboembolic disorders; patients on heparin or Coumadin ineligible
- ✕Carotid artery encasement by primary tumor or lymph node
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Concurrent Angiogenic and EGFR Blockade in Conjunction With Curative Intent Chemoradiation for Locally Advanced Head and Neck Cancer
In Brief
A Early Phase 1 clinical trial evaluating Chemoradiotherapy, Cisplatin, and 2 other interventions for Head and Neck Cancer and Pharynx Cancer. Completed, enrolled 28 participants across 1 site.
Detailed Summary
Radiotherapy (RT) with concurrent chemotherapy represents the state of the art in curative intent treatment for locally advanced squamous carcinoma of the head and neck. Tumor hypoxia and high levels of angiogenesis (blood vessel formation) are associated with treatment failure. Preclinical models reveal that radiotherapy itself may induce tumor secretion of vascular endothelial growth factor (VEGF). Curability may consequently be reduced by multiple mechanisms. Over-expression of epidermal growth factor receptor (EGFR) also occurs commonly and increases the risk of treatment failure. The addition of EGFR blockade to RT alone increases the chance of a cure. Concurrent VEGF and EGFR blockade could be synergistic with one another and improve the effectiveness of concurrent chemoradiation for advanced head and neck cancer. This study will add angiogenic and epidermal growth factor receptor (EGFR) blockade into an established program of curative intent concurrent chemoradiation for locally advanced head and neck cancer. The safety and effectiveness of delivering the drugs bevacizumab and Tarceva in conjunction with twice daily irradiation and concurrent cisplatin (CDDP) chemotherapy will be determined.
Study Details
Timeline
Interventions
External beam radiation daily (M-F)
Cisplatin week 1 and 5 of radiation
Bevacizumab (Avastin) day 1 of weeks 1, 3, and 5 of radiation
Erlotinib daily during radiation