Cisplatin or Carboplatin Combined With Gemcitabine in Treating Patients With Locally Advanced, Recurrent, or Metastatic Malignant Salivary Gland Tumor
RATIONALE: Drugs used in chemotherapy, such as cisplatin, carboplatin, and gemcitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving more than one drug may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving gemcitabine together with either cisplatin or carboplatin works in treating patients with locally advanced, recurrent, or metastatic malignant salivary gland tumor (cancer).
Head and Neck Cancer
Drug: gemcitabine hydrochloride
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Cisplatin and Gemcitabine in Patients With Locally Advanced/Recurrent or Metastatic Malignant Salivary Gland Tumors|
- Objective response measured by RECIST criteria after accrual of 11 evaluable patients [ Designated as safety issue: No ]
- Toxicity assessed by NCI CTC v2.0 [ Designated as safety issue: Yes ]
- Overall survival [ Designated as safety issue: No ]
|Study Start Date:||October 2003|
|Study Completion Date:||February 2009|
|Primary Completion Date:||September 2008 (Final data collection date for primary outcome measure)|
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00079079
|Winnipeg, Manitoba, Canada, R3E 0V9|
|London Regional Cancer Program at London Health Sciences Centre|
|London, Ontario, Canada, N6A 4L6|
|Ottawa Hospital Regional Cancer Centre - General Campus|
|Ottawa, Ontario, Canada, K1H 8L6|
|Princess Margaret Hospital|
|Toronto, Ontario, Canada, M5G 2M9|
|Study Chair:||Lillian L. Siu, MD, FRCPC||Princess Margaret Hospital, Canada|