Cisplatin or Carboplatin Combined With Gemcitabine in Locally Advanced, Recurrent, or Metastatic Malignant Salivary Gland Tumor
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|ClinicalTrials.gov Identifier: NCT00079079|
Recruitment Status : Completed
First Posted : March 9, 2004
Last Update Posted : April 6, 2020
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).
|Condition or disease||Intervention/treatment||Phase|
|Head and Neck Cancer||Drug: carboplatin Drug: cisplatin Drug: gemcitabine hydrochloride||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||34 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Cisplatin and Gemcitabine in Patients With Locally Advanced/Recurrent or Metastatic Malignant Salivary Gland Tumors|
|Actual Study Start Date :||October 23, 2003|
|Actual Primary Completion Date :||September 29, 2008|
|Actual Study Completion Date :||February 10, 2009|
- Objective response measured by RECIST criteria after accrual of 11 evaluable patients
- Toxicity assessed by NCI CTC v2.0
- Overall survival
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|