Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00123825
Status:
COMPLETED
Last Update Posted:
2007-12-21
First Post:
2005-07-25
Brief Title:
Gemcitabine and Cisplatin for Gallbladder and Biliary Tract Cancer
Sponsor:
Dana-Farber Cancer Institute
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
A Phase II Trial of Gemcitabine and Cisplatin In Unresectable Or Metastatic Biliary Tract and Gallbladder Cancer
Status:
COMPLETED
Status Verified Date:
2007-12
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:
In the United States the incidence of biliary tract cancer and gallbladder cancer has been estimated to be 6000-8000 patients per year Currently there is no standard therapy for these tumors once the disease has spread and is inoperable Recent small studies with gemcitabine have shown a positive response rate The investigators plan to test the combination of gemcitabine with cisplatin for biliary tract and gallbladder cancers
Detailed Description:
Gemcitabine and cisplatin will be administered weekly for two weeks on day 1 and day 8 followed by a one week rest period 1 cycle is 3 weeks On day one and eight of each cycle the patient will have a physical exam and blood work During the first two cycles additional blood work will be drawn on day 15 as well Reassessment of the tumor will be performed at 6 weeks 12 weeks and every 9 weeks thereafter Patients will remain on treatment until further evidence of disease progression or unacceptable side effects occur
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