Phase I Study of Intraarterial ONYX-015 in Combination With Intravenous Cisplatin and Fluorouracil in Patients With Advanced Squamous Cell Cancer of the Head and Neck
OBJECTIVES:
I. Determine the feasibility and maximum tolerated dose (MTD) of intraarterial ONYX-015 in
patients with advanced squamous cell cancer of the head and neck.
II. Determine the feasibility and tolerability of intraarterial ONYX-015 at the MTD OR
maximum theraputic dose, whichever is lower, in combination with intravenous cisplatin and
fluorouracil in these patients.
III. Determine the qualitative distribution of ONYX-015 within a limited tumor biopsy and a
normal mucosal biopsy at different dose levels.
IV. Determine the response of these patients to intraarterial ONYX-015. V. Determine the
response of these patients to cisplatin and fluorouracil following intraarterial ONYX-015.
PROTOCOL OUTLINE: This is a dose escalation study. Patients receive intraarterial infusions
of ONYX-015. Treatment repeats once in 3-4 weeks in the absence of disease progression or
unacceptable toxicity.
Cohorts of 3-8 patients receive escalating doses of ONYX-015 until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 5
patients experience dose limiting toxicity.
Patients in cohorts 1-4 are followed for 5 days after infusion, weekly for 3 weeks, at week
6, and monthly thereafter for 4 months.
A fifth or final cohort of 10 patients will receive ONYX-015 at the MTD. If the MTD was not
determined in cohorts 1-4, patients receive the highest dose administered to cohort 4.
Beginning 1-2 days after ONYX-015 infusion, patients receive cisplatin IV over 30-60 minutes
once and fluorouracil IV continuously over 4 days. Treatment repeats in 4 weeks in the
absence of disease progression or unacceptable toxicity. Cisplatin and fluorouracil IV
treatment continues every 3-4 weeks at the discretion of the treating oncologist.
Patients in cohort 5 are followed for 5 days after initial infusion, weekly for 4 weeks, at
week 8, and monthly thereafter for 4 months.
PROJECTED ACCRUAL:
A total of 23-28 patients will be accrued for this study.
Interventional
Primary Purpose: Treatment
Marshall R. Posner
Study Chair
Dana-Farber Cancer Institute
United States: Federal Government
CDR0000068117
NCT00006106
July 1999
Name | Location |
---|---|
Massachusetts General Hospital Cancer Center | Boston, Massachusetts 02114 |
Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |