A Phase I/II Study Using Cisplatin and Gemcitabine (Gemzar) for Advanced Head and Neck Cancer (Squamous Cell Carcinoma)
OBJECTIVES: I. Determine the maximum tolerated dose and dose limiting toxicity of
gemcitabine used in combination with cisplatin in the treatment of squamous cell carcinoma
of the head and neck. II. Determine the toxicity profile of this combination treatment in
these patients. III. Assess the response rate of treatment in these patients.
OUTLINE: This is a dose escalation study of gemcitabine. Patients receive gemcitabine as an
IV bolus on day 1 every 2 weeks. Cisplatin is administered on day 1 every 2 weeks. In the
absence of dose limiting toxicity (DLT) in the first 3 patients treated, subsequent cohorts
of 3 patients each receive escalating doses of gemcitabine on the same schedule. If 1 of 3
patients in each cohort experiences DLT, an additional 3 patients are enrolled at that same
dose level. If 2 of 3 patients experiences DLT in the cohort, then dose escalation ceases
and the next lower dose is declared the maximum tolerated dose. Patients are assessed for
response every 2 weeks. Patients may continue treatment for up to 9 months or until disease
PROJECTED ACCRUAL: At least 3 patients will be accrued for phase I and 20-40 patients will
be accrued for phase II of this study.
Primary Purpose: Treatment
Raj Sadasivan, MD, PhD
Hope Cancer Institute, Inc.
United States: Federal Government
|Bethany Medical Center||Kansas City, Kansas 66102|
|Heartland Cancer Research Network||Kansas City, Kansas 66102|