Clinical Trials: Head & Neck Cancer

Cell Therapeutics, Inc.: A Phase I/II Study of Radiation Therapy, Paclitaxel Poliglumex and Cetuximab in Advanced Head and Neck Cancer

Inclusion/Exclusion

Stage III or IV squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx; measurable disease; no prior chemotherapy or anticancer biologic therapy for any cancer; no prior radiotherapy for head and neck cancer; PS 0-1

Details: Phase I of this study is designed to find out the maximum dose of paclitaxel poliglumex (PPX) which can be safely given to subjects when combined with cetuximab and radiotherapy in head and neck cancer. The first three enrolled subjects will receive PPX at a dose of 40 mg/m2, and the effects of the treatment (both good and bad) will be carefully monitored for four weeks following treatment. If no dose-limiting toxicities are observed, the dose of PPX will be increased to 50 mg/m2 for the next cohort of three subjects. Similar increases will continue until unacceptable side effects are observed, or up to a maximum dose of 80 mg/m2. The next lower dose prior to the appearance of unacceptable side effects will be administered to 24 additional subjects enrolled in the Phase II portion of this study.

PHASE I—Determination of the maximum tolerated dose of PPX when used in combination with cetuximab and radiation therapy for locally advanced head and neck cancer

• Cetuximab loading dose on Week 1, Day 1
• Cetuximab and PPX (40–80 mg/m2, according to cohort) on Days 8, 15, 22, 29, 36, 43, & 50
• Radiotherapy (IMRT) once daily, Mon–Fri, beginning Day 8, for 6–7 wks (total = 70 Gy)

PHASE II—Determination of the rate of locoregional disease control at one year

• Cetuximab loading dose on Week 1, Day 1
• Cetuximab and PPX (dose determined in Phase I) on Days 8, 15, 22, 29, 36, 43, & 50
• Radiotherapy (IMRT) once daily, Mon-Fri, beginning Day 8, for 6–7 wks (total = 70 Gy)

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