Ignite Creation Date:
2024-05-05 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00079079
Status:
COMPLETED
Last Update Posted:
2023-08-04
First Post:
2004-03-08
Brief Title:
Cisplatin or Carboplatin Combined With Gemcitabine in Locally Advanced Recurrent or Metastatic Malignant Salivary Gland Tumor
Sponsor:
NCIC Clinical Trials Group
Organization:
Canadian Cancer Trials Group
Study Overview
Official Title:
A Phase II Study of Cisplatin and Gemcitabine in Patients With Locally AdvancedRecurrent or Metastatic Malignant Salivary Gland Tumors
Status:
COMPLETED
Status Verified Date:
2020-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
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 15-3 years
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 15-3 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CAN-NCIC-HN4 | OTHER | None | None |
| LILLY-CAN-NCIC-HN4 | OTHER | None | None |
| CDR0000353487 | OTHER | PDQ | None |