Ignite Creation Date:
2024-05-05 @ 5:19 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00436423
Status:
COMPLETED
Last Update Posted:
2007-11-01
First Post:
2007-02-16
Brief Title:
A Phase Ⅱ Study of Gemcitabine Combination With TS-1 in Patient With Advanced or Recurred Pancreatic Cancer
Sponsor:
Korea University Anam Hospital
Organization:
Korea University Anam Hospital
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2007-10
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 primary objective of the study is to Evaluate the response rate of Gemcitabine with TS-1 in Korean patient with advanced but inoperable metastatic or recurrent pancreatic cancer who is not receiving anti cancer therapy
Detailed Description:
To date curative treatment of pancreatic cancer is surgeryBut patients with operable indication are rare most of patients present with locally advanced or general advanced stage at diagnosis Thus the majority of patients need chemotherapyBut efficacy outcomes have not seemed to increase overall survival comparing with none treated control groupIn Korea the incidence of pancreatic cancer increases steadily Prognosis is poor So now the effective treatment is necessaryThere are no phase 2 trialsabout combining gemcitabine and TS-1 against advanced pancreatic canceraccording to phase 1 trial of advanced pancreatic cancer nakamura et altoxicities more than 3 grade are neutropenia anemia thrombocytopenia anorexia etc that can be treatedPhase 1 trial is not study to evaluate the response rate But among 21 patients who can be evaluated the response rate 10 patients have Partial response or Complete responseThis combination therapy seemed to havetolerable toxicity and remarkable therapeutic effect for locally advanced or metastatic pancreatic cancerSo therapy combining gemcitabine with TS-1 is expected synergic and additional effect
This trial is phase 2 open-label multi-center single arm study The total sample size will be 38 patients Patient will be administered chemotherapy until disease progression Gemcitabine will be administered at a dose of 1000 mgm2 every 3weeks on day 1 of each cycle TS-1 will be administered 80 mgm2 orally twice daily for 14 days every 3 weeks
This trial is phase 2 open-label multi-center single arm study The total sample size will be 38 patients Patient will be administered chemotherapy until disease progression Gemcitabine will be administered at a dose of 1000 mgm2 every 3weeks on day 1 of each cycle TS-1 will be administered 80 mgm2 orally twice daily for 14 days every 3 weeks
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