A Phase II Study of Gemcitabine in Combination With Doxorubicin for Patients With Head and Neck Cancer
- To determine the overall response rate (complete and partial response) produced by the
combination of gemcitabine hydrochloride and doxorubicin hydrochloride in patients with
recurrent or progressive head and neck cancer.
- To describe the overall and progression-free survival of patients treated with the
- To describe the duration of response (complete and partial response) among patients who
attain a response.
- To evaluate the toxicity associated with the administration of the combination in
previously treated head and neck cancer patients.
- To establish a correlation of the cytotoxicity of these agents with cell cycle-arrest
and apoptosis in cancer cells, particularly involving the sphingolipid pathway.
OUTLINE: Patients receive gemcitabine hydrochloride IV over 30 minutes and doxorubicin
hydrochloride IV over 5-10 minutes on days 1 and 8. Treatment repeats every 3 weeks for at
least 2 courses in the absence of disease progression or unacceptable toxicity.
Patients undergo blood sample collection at baseline and after every 2 courses for
correlative studies. Samples are analyzed for plasma/serum sphingosine-1-phosphate,
ceramide, and other markers of the apoptotic pathway via LC/MS.
After completion of study treatment, patients are followed every 6 months for up to 3 years.
Masking: Open Label, Primary Purpose: Treatment
Response rate (complete and partial response)
Medical University of South Carolina
United States: Federal Government
|Hollings Cancer Center at Medical University of South Carolina||Charleston, South Carolina 29425|