Gemcitabine and Doxorubicin in Treating Patients With Recurrent or Progressive Head and Neck Cancer
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and doxorubicin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving gemcitabine together with doxorubicin works in treating patients with recurrent or progressive head and neck cancer.
Head and Neck Cancer
Drug: doxorubicin hydrochloride
Drug: gemcitabine hydrochloride
Other: laboratory biomarker analysis
Other: liquid chromatography
Other: mass spectrometry
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Gemcitabine in Combination With Doxorubicin for Patients With Head and Neck Cancer|
- Response rate (complete and partial response) [ Designated as safety issue: No ]
- Median and 1-year survival [ Designated as safety issue: No ]
- Time to treatment failure [ Designated as safety issue: No ]
- Progression-free survival [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
- Toxicity [ Designated as safety issue: Yes ]
|Study Start Date:||June 2005|
|Study Completion Date:||May 2011|
|Primary Completion Date:||May 2011 (Final data collection date for primary outcome measure)|
- 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 chemotherapy combination.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00509665
|United States, South Carolina|
|Hollings Cancer Center at Medical University of South Carolina|
|Charleston, South Carolina, United States, 29425|
|Principal Investigator:||Paul O'Brien||Medical University of South Carolina|