NCT00405405

Phase I of Biologics and Chemoradiation Therapy for Advanced Head and Neck Cancer

A Phase I Study of the Combination of Chemoradiotherapy With Biologic Therapy for Advanced Head and Neck Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To determine a safe and effective doses of two biologic drugs, erlotinib and bevacizumab when used with chemotherapy and radiation therapy in advanced head and neck cancer

Detailed description

Locally advanced non-operative, Stage IV head and neck cancer has at best a guarded prognosis. Improvements in outcome have been achieved via the combination of chemotherapy and radiotherapy. Concurrent chemoradiotherapy is needed to optimize results, although recent data suggest a benefit from induction therapy as well. Nonetheless, despite high remission rates, most of these patients will suffer local-regional and/or distant recurrence from their disease. The proposed study will build upon the framework of chemoradiotherapy (induction plus concurrent) via the addition of a double biologic therapy. Specifically, the combination of bevacizumab and erlotinib will be used, as has been studied in other types of cancer.

Conditions

• Head and Neck Cancer
• Parotid Gland Cancer
• Thyroid Gland Cancer
• Melanoma
• Stage IV Head and Neck Cancer

Interventions

Type	Name	Description
DRUG	Cisplatin	* Two cycles during neoadjuvant therapy * Response assessment at approximately day 36 * Concurrent biochemoradiotherapy
DRUG	Docetaxel	* Two cycles during neoadjuvant therapy * Response assessment at approximately day 36 * Concurrent biochemoradiotherapy
DRUG	Bevacizumab	* Two cycles during neoadjuvant therapy * Response assessment at approximately day 36 * Concurrent biochemoradiotherapy
DRUG	Erlotinib	* Two cycles during neoadjuvant therapy (dose escalation) * Response assessment at approximately day 36 * Concurrent biochemoradiotherapy
RADIATION	Radiotherapy	Radiotherapy begins as soon as possible following neoadjuvant chemotherapy, and continues for 7 weeks

Timeline

• Start date: 2006-12-01
• Primary completion: 2010-06-01
• Completion: 2010-06-01
• First posted: 2006-11-30
• Last updated: 2025-05-06

Locations

1 site across 1 country: United States