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MLN8237 in Head and Neck Cancer

Head and Neck Cancer Clinical Trial

Official title:
Phase I Study of MLN8237 in Combination With Cetuximab and Definitive Radiation in Patients With Locoregionally Advanced Squamous Cell Carcinoma of the Head and Neck

Clinical Trial Summary

This study will evaluate the initial safety and effectiveness of an investigational drug, MLN8237, added to routine radiation therapy and cetuximab in patients with head and neck cancer. This study will also determine the highest dose of MLN8237 that can be given together with cetuximab and radiation therapy without causing severe side effects.

Clinical Trial Description

This is a phase 1b study of MLN8237, cetuximab and definitive radiation therapy for patients with previously untreated locoregionally advanced HNSCC who are candidates for definitive radiation therapy with curative intent with cetuximab as the radiosensitizer. The treatment regimen consists of MLN8237 po bid for 7 days followed by 2 weeks off for 4 cycles with the first 3 cycles of MLN8237 concurrent with RT. Three dose levels of MLN8237 are planned: 30, 40 and 50 mg po bid. Cetuximab will be given at the FDA-approved loading and maintenance doses starting ~ 1 week prior to the initiation of radiation therapy and continuing for a grand total of 12 weeks. Radiotherapy will be administered in 2-Gy fractions, 5 days a week, to total dose of ~70 Gy according to standard departmental protocols. Correlative biomarker assays on pre- and on-therapy biopsy specimens (tissue micro arrays analyzed by AQUA quantitative immunofluorescence) will seek to establish proof-of-mechanism by determining if the novel drug combination has the predicted effects on biochemical signaling pathways linked to Aurora A and EGFR. Tumor samples will also be analyzed for Aurora A and EGFR expression by IHC and FISH. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01540682
Study type Interventional
Source Abramson Cancer Center of the University of Pennsylvania
Contact
Status Completed
Phase Phase 1
Start date February 2012
View Details
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