A Phase II Study of Cisplatin and Gemcitabine in Patients With Locally Advanced/Recurrent or Metastatic Malignant Salivary Gland Tumors
OBJECTIVES:
Primary
- Determine the activity of cisplatin or carboplatin in combination with gemcitabine, in
terms of response rate, in patients with locally advanced, recurrent, or metastatic
malignant salivary gland tumor.
Secondary
- Determine the complete response in patients treated with these regimens.
- Determine the duration of response in patients treated with these regimens.
- Determine the toxicity profile of these regimens in these patients.
- Determine the overall survival of patients treated with these regimens.
OUTLINE: This is a multicenter study.
Patients receive gemcitabine IV over 30 minutes on days 1 and 8. Patients also receive
either cisplatin IV over 1 hour on day 2 OR carboplatin IV over 30 minutes on day 1.
Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or
unacceptable toxicity.
Patients are followed at 4 weeks, every 3 months for 1 year, and then every 6 months
thereafter until relapse.
PROJECTED ACCRUAL: A total of 11- 34 patients will be accrued for this study within 1.5-3
years.
Interventional
Masking: Open Label, Primary Purpose: Treatment
Objective response measured by RECIST criteria after accrual of 11 evaluable patients
No
Lillian L. Siu, MD, FRCPC
Study Chair
Princess Margaret Hospital, Canada
United States: Federal Government
HN4
NCT00079079
October 2003
February 2009
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