Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Gland and Hormone Related Diseases

Rare Diseases

Melanoma

Thyroid Neoplasms

Thyroid Diseases

Head and Neck Neoplasms

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Endocrine System Diseases

Endocrine Gland Neoplasms

Neuroendocrine Tumor

Neuroepithelioma

Antineoplastic Agents

All Drugs and Chemicals

Amino Acids

Docetaxel

Bevacizumab

Cisplatin

Erlotinib Hydrochloride

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

Tubulin Modulators

Antimitotic Agents

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

A combination of Cisplatin, Docetaxel, Bevacizumab, Erlotinib, and Radiotherapy

* Two cycles during neoadjuvant therapy
* Response assessment at approximately day 36
* Concurrent biochemoradiotherapy

* Two cycles during neoadjuvant therapy (dose escalation)
* Response assessment at approximately day 36
* Concurrent biochemoradiotherapy

Erlotinib

Radiotherapy begins as soon as possible following neoadjuvant chemotherapy, and continues for 7 weeks

Radiotherapy

Pramila Rani Anne, MD

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

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.

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

To determine if bevacizumab and erlotinib can be safely combined with chemoradiotherapy for advanced head and neck cancer.

To determine the appropriate dosing strategy for bevacizumab/erlotinib when combined with chemoradiotherapy for advanced head and neck cancer.

To obtain preliminary data on the complete remission rate for this treatment combination.

Genentech, Inc.

Sidney Kimmel Cancer Center at Thomas Jefferson University

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Phase I of Biologics and Chemoradiation Therapy for Advanced Head and Neck Cancer	NCT00405405	Head and Neck C... Parotid Gland C... Thyroid Gland C... Melanoma Stage IV Head a...	Cisplatin Docetaxel Bevacizumab Erlotinib Radiotherapy	18 Years -	Thomas Jefferson University
Phase I of Biologics and Chemoradiation Therapy for Advanced Head and Neck Cancer	NCT00405405	Head and Neck C... Parotid Gland C... Thyroid Gland C... Melanoma Stage IV Head a...	Cisplatin Docetaxel Bevacizumab Erlotinib Radiotherapy	18 Years -	Thomas Jefferson University

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