Trial Information

A Phase III Double-Blind, Randomised, Placebo-Controlled Study of Porfiromycin When Used as an Adjuvant to Radiation Therapy in Patients With Head and Neck Cancer

OBJECTIVES: I. Determine the time to tumor progression in patients with stage III or IV
(without distant metastases) head and neck cancer treated with porfiromycin as adjuvant
therapy to radiotherapy. II. Determine percentage of patients with locoregional tumor
recurrence up to 2 years posttreatment. III. Determine response rate, disease free survival
time, and overall survival time in these patients. IV. Evaluate the safety and tolerance of
porfiromycin in these patients.

OUTLINE: This is a randomized, double blind, placebo controlled, multicenter study. Patients
are stratified according to primary tumor site (oral vs pharynx vs larynx) and disease stage
(both T and N stage: T1-2 vs T3-4 and N0 vs N1-2 vs N3). All patients are randomized to
receive either porfiromycin (arm I) or placebo (arm II) as adjuvant therapy to radiation
therapy. Both arms follow the same treatment schedule. Daily radiation therapy commences on
day 1. Patients receive porfiromycin or placebo by intravenous infusion over 30-60 minutes
on day 5 and then on day 46 or 47. Porfiromycin or placebo is administered 30 minutes to 2
hours following radiation therapy. All patients with N3 neck disease (metastases in a lymph
node more than 6 cm in greatest dimension) undergo a planned neck dissection following
external beam radiation at 4 to 12 weeks following therapy. This surgery is not needed for
patients with N3 neck disease who do not have residual disease following radiotherapy.
Patients are followed at 4 weeks, then every 2 months for 2 years, and then every 6 months
for 3 years.

PROJECTED ACCRUAL: A total of 550-600 patients will be accrued for this study within 3
years.