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| ID | Type | Description | Link |
|---|---|---|---|
| CAN-NCIC-HN4 | Other Identifier | PDQ | |
| LILLY-CAN-NCIC-HN4 | Other Identifier | LILLY | |
| CDR0000353487 | Other Identifier | PDQ |
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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).
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| carboplatin | Drug | |||
| cisplatin | Drug | |||
| gemcitabine hydrochloride | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response measured by RECIST criteria after accrual of 11 evaluable patients |
| Measure | Description | Time Frame |
|---|---|---|
| Toxicity assessed by NCI CTC v2.0 | ||
| Overall survival |
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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:
No bone metastases as only site of measurable disease
No known brain metastasis
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
See Disease Characteristics
At least 4 weeks since prior chemotherapy for locally advanced, recurrent, or metastatic disease and recovered
More than 12 months since prior adjuvant chemotherapy (including cisplatin/carboplatin-based regimens) and recovered
No prior gemcitabine
Endocrine therapy
Radiotherapy
Surgery
Other
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| Name | Affiliation | Role |
|---|---|---|
| Lillian L. Siu, MD, FRCPC | Princess Margaret Hospital, Canada | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CancerCare Manitoba | Winnipeg | Manitoba | R3E 0V9 | Canada | ||
| London Regional Cancer Program at London Health Sciences Centre |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19924794 | Result | Laurie SA, Siu LL, Winquist E, Maksymiuk A, Harnett EL, Walsh W, Tu D, Parulekar WR. A phase 2 study of platinum and gemcitabine in patients with advanced salivary gland cancer: a trial of the NCIC Clinical Trials Group. Cancer. 2010 Jan 15;116(2):362-8. doi: 10.1002/cncr.24745. |
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| London |
| Ontario |
| N6A 4L6 |
| Canada |
| Ottawa Hospital Regional Cancer Centre - General Campus | Ottawa | Ontario | K1H 8L6 | Canada |
| Princess Margaret Hospital | Toronto | Ontario | M5G 2M9 | Canada |
| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D012468 | Salivary Gland Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009062 | Mouth Neoplasms |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D012466 | Salivary Gland Diseases |
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| ID | Term |
|---|---|
| D016190 | Carboplatin |
| D002945 | Cisplatin |
| D000093542 | Gemcitabine |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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