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A Study of RAD001 in Combination With Cetuximab and Cisplatin in Recurrent and Metastatic Squamous Cell Cancer of the Head and Neck

2014-07-24 14:10:59 | BioPortfolio

Summary

1. Phase I: To estimate the Maximum Tolerated Dose (MTD) of RAD001 in combination with cetuximab and cisplatin for treatment of metastatic squamous cell cancer of the head and neck (SCCHN).

2. Phase II: To estimate the progression free survival (PFS) of RAD001 at MTD in combination with weekly cetuximab and cisplatin on days 1 and 8 of each 28 day cycle in patients with recurrent or metastatic SCCHN,

Secondary Objectives

1. To estimate the complete and partial response rate of RAD001 at MTD in combination with weekly cetuximab and cisplatin on days 1 and 8 of each 28 day cycle in patients with recurrent or metastatic SCCHN,

2. To explore if the clinical activity of this regimen correlates with markers of the EGF-R/mTOR pathway in tumor tissue by serial sampling of tumor.

3. To explore the role of FDG PET imaging as an early indicator of response to this combination.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Head and Neck Cancer

Intervention

RAD001, Cetuximab, Cisplatin/Carboplatin

Location

Johns Hopkins University
Baltimore
Maryland
United States
21231

Status

Recruiting

Source

Sidney Kimmel Comprehensive Cancer Center

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-24T14:10:59-0400

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Medical and Biotech [MESH] Definitions

Soft tissue tumors or cancer arising from the mucosal surfaces of the LIP; oral cavity; PHARYNX; LARYNX; and cervical esophagus. Other sites included are the NOSE and PARANASAL SINUSES; SALIVARY GLANDS; THYROID GLAND and PARATHYROID GLANDS; and MELANOMA and non-melanoma skin cancers of the head and neck. (from Holland et al., Cancer Medicine, 4th ed, p1651)

Dissection in the neck to remove all disease tissues including cervical LYMPH NODES and to leave an adequate margin of normal tissue. This type of surgery is usually used in tumors or cervical metastases in the head and neck. The prototype of neck dissection is the radical neck dissection described by Crile in 1906.

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A symptom, not a disease, of a twisted neck. In most instances, the head is tipped toward one side and the chin rotated toward the other. The involuntary muscle contractions in the neck region of patients with torticollis can be due to congenital defects, trauma, inflammation, tumors, and neurological or other factors.

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