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Sponsored by: |
National Cancer Institute of Canada |
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00079079 |
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 | Intervention | Phase |
Head and Neck Cancer |
Drug: carboplatin Drug: cisplatin Drug: gemcitabine hydrochloride |
Phase II |
MedlinePlus related topics: | Cancer Head and Neck Cancer Salivary Gland Disorders |
Drug Information available for: | Carboplatin Cisplatin Gemcitabine hydrochloride Gemcitabine |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Study of Cisplatin and Gemcitabine in Patients With Locally Advanced/Recurrent or Metastatic Malignant Salivary Gland Tumors |
Estimated Enrollment: | 34 |
Study Start Date: | October 2003 |
Estimated Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed malignant salivary gland tumor
Disease must meet 1 of the following criteria:
At least 1 site of unidimensionally measurable disease documented by 1 of the following:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
At least 4 weeks since prior chemotherapy for locally advanced, recurrent, or metastatic disease and recovered
Endocrine therapy
Radiotherapy
Surgery
Other
Canada, Manitoba | |||||
CancerCare Manitoba | |||||
Winnipeg, Manitoba, Canada, R3E 0V9 | |||||
Canada, Ontario | |||||
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 |
National Cancer Institute of Canada |
Study Chair: | Lillian L. Siu, MD, FRCPC | Princess Margaret Hospital, Canada |
Clinical trial summary from the National Cancer Institute's PDQ® database 
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Study ID Numbers: | CDR0000353487, CAN-NCIC-HN4, LILLY-CAN-NCIC-HN4 |
First Received: | March 8, 2004 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00079079 |
Health Authority: | United States: Federal Government |
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