Ignite Creation Date:
2024-05-05 @ 9:36 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003744
Status:
COMPLETED
Last Update Posted:
2017-01-19
First Post:
1999-11-01
Brief Title:
Gemcitabine in Treating Patients With Advanced Salivary Gland Cancer That Cannot Be Removed During Surgery
Sponsor:
Dana-Farber Cancer Institute
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
Gemcitabine for Advanced Salivary Cancer A Phase II Study
Status:
COMPLETED
Status Verified Date:
2017-01
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:
The purpose of this study is to see how patients with incurable salivary gland cancer who have not had chemotherapy before respond to Gemcitabine The investigators are trying to find out what effects good and bad Gemcitabine has on participants and salivary gland cancer
Gemcitabine has been shown to be an effective chemotherapy agent in other types of cancer including bladder cancer breast cancer certain types of lung cancer ovarian cancer and pancreas cancer Gemcitabine has yet to be studied for efficacy in subjects with salivary gland cancer and in general other chemotherapy drugs have shown to be ineffective so far in this population
Gemcitabine has been shown to be an effective chemotherapy agent in other types of cancer including bladder cancer breast cancer certain types of lung cancer ovarian cancer and pancreas cancer Gemcitabine has yet to be studied for efficacy in subjects with salivary gland cancer and in general other chemotherapy drugs have shown to be ineffective so far in this population
Detailed Description:
OBJECTIVES
Evaluate the response rate of patients with incurable salivary gland cancer treated with gemcitabine
Evaluate the time to progression and toxicity of this therapy in these patients
OUTLINE This is a multicenter study
Patients receive gemcitabine IV for 30 minutes on days 1 8 and 15 of each 28 day course Patients receive a minimum of 2 courses of treatment Patients may continue treatment in the absence of disease progression or unacceptable toxicity
Patients are followed every 2 months
Evaluate the response rate of patients with incurable salivary gland cancer treated with gemcitabine
Evaluate the time to progression and toxicity of this therapy in these patients
OUTLINE This is a multicenter study
Patients receive gemcitabine IV for 30 minutes on days 1 8 and 15 of each 28 day course Patients receive a minimum of 2 courses of treatment Patients may continue treatment in the absence of disease progression or unacceptable toxicity
Patients are followed every 2 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
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 |
|---|---|---|---|
| NCI-G99-1496 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA006516 |
| P30CA006516 | NIH | None | None |
| DFCI-98168 | None | None | None |
| LILLY-DFCI-98168 | None | None | None |