Phase II Study of Capecitabine and Oxaliplatin (XELOX) in Patients With Locally Advanced, Incurable, Salivary Gland Cancers
- Determine the tumor response rate in patients with unresectable locally advanced or
metastatic incurable salivary gland cancer treated with capecitabine and oxaliplatin.
- Determine time to disease progression in patients treated with this regimen.
- Determine the toxicity profile of this drug in these patients.
OUTLINE: This is a nonrandomized study.
Patients receive oral capecitabine twice daily on days 1-14 and oxaliplatin IV over 2 hours
on day 1. Treatment repeats every 21 days for 2 courses in the absence of disease
progression or unacceptable toxicity. Patients achieving a positive response after 2 courses
receive additional courses of therapy in the absence of disease progression or unacceptable
toxicity. Patients achieving a complete response (CR) receive 2 additional courses of
treatment beyond CR.
After completion of study treatment, patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 33 patients will be accrued for this study.
Masking: Open Label, Primary Purpose: Treatment
Tumor response rate as assessed by RECIST criteria at every 2 courses of treatment
Robert I. Haddad, MD
Dana-Farber Cancer Institute
United States: Federal Government
|Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute||Boston, Massachusetts 02115|