Phase II Study of Gemcitabine and TS-1 in Biliary Trat Cancer (GetBil)
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|ClinicalTrials.gov Identifier: NCT01171755|
Recruitment Status : Terminated (The objective response rate by more than two people are confirmed.)
First Posted : July 28, 2010
Last Update Posted : May 21, 2014
|Condition or disease||Intervention/treatment||Phase|
|Biliary Tract Cancer||Drug: Gemcitabine TS-1||Phase 2|
At present, surgery is the only curative treatment option for biliary tract cancer (BTC). However, less than 25% of patients are resectable at presentation with high relapse rates after surgery. Because of the low incidence and heterogeneity of BTC, clinical trials are difficult to conduct in these patients, hampering the evaluation of optimal chemotherapy regimens. Owing to the lack of randomized phase III studies, there is no standard regimen for palliative chemotherapy of GBC and CC. But the exploration of an optimal regimen for standard first-line chemotherapy for BTC is imperative in order to improve survival in these patients.
Gemcitabine has demonstrated antitumor activity as monotherapy in phase II trials in BTC patients with response rates ranging from 22 to 36% (2001 Proc Am Soc Clin Oncol 20:A626, 2001 J Clin Oncol 19(20):4089-4091, 2001 Ann Oncol 12(2):183-186).
As with most gastrointestinal tumors, 5-fluorouracil (5-FU) is the most studied drug as a single agent or a combination in different dosages and schedules with response rates of 10-20% and with median survival of 7-9 months in BTC (2005 Cancer 103:111-118, 2001 Clin Cancer Res 7:3375-3380).
The combination of gemcitabine and fluoropyrimidine in biliary cancers is worthy of further evaluation. The toxicity profiles of these agents are known to be non-overlapping, and combinations have been well tolerated. Oral fluoropyrimidines are considered to be an alternative to conventional protracted 5-FU infusion as far as they provide comparable efficacy and compliance.
S-1 is oral fluoropyrimidine preparation developed by Taiho Pharmaceutical Co., Ltd. (Tokyo, Japan) that combines tegafur with two 5-FU modulators, 5-chloro-2, 4-dihydroxypyridine (CDHP) and potassium oxonate (Oxo), in a molar ratio of 1:0.4:1. Tegafur, a prodrug of 5-FU, is converted to 5-FU mainly in liver and tumor cells. CDHP, a reversible inhibitor of dihydropyrimidine dehydrogenase, suppresses the degradation of 5-FU, thereby maintaining high concentrations of 5-FU in plasma and tumor cells. CDHP also decreases cardiotoxic and neurotoxic effects by reducing the production of F-b-alanine (FBAL), the main catabolite of 5-FU. Several phase II trials showed that TS-1 monotherapy or combination with CDDP, paclitaxel or irinotecan was effective palliative treatment option for advanced gastric cancer and colorectal cancer.
In current study, we evaluate the efficacy of gemcitabine and TS-1 combination chemotherapy in advanced BTC.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||19 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Gemcitabine and TS-1 in Patients With Previously Untreated Metastatic or Recurrent Biliary Tract Cancer|
|Study Start Date :||February 2008|
|Primary Completion Date :||December 2009|
|Study Completion Date :||December 2009|
Experimental: Gemcitabine, Ts-1
Gemcitabine : 1000/m2 will be administered on days 1 and 8 at every 3 weeks . TS-1 will be administered orally according to body surface area (BSA) as follows : BSA<1.25 M2, 80 mg/day; 1.25 M2≤BSA<1.5 M2, 100 mg/day; 1.5 M2≤BSA, 120 mg/day for 14 consecutive days followed by a 7-day rest.
Drug: Gemcitabine TS-1
Gemcitabine (1,000mg/m2) will be administered on days 1 and 8 at every 3 weeks TS-1 will be administered orally according to body surface area (BSA) as follows : BSA<1.25 M2, 80 mg/day; 1.25 M2≤BSA<1.5 M2, 100 mg/day; 1.5 M2≤BSA, 120 mg/day for 14 consecutive days followed by a 7-day rest.
Other Name: Gemcitabine (Gemza)TS-1 (TS-1)
- Response rate [ Time Frame: 1year 6months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01171755
|Principal Investigator:||Yeong Lim Lim, Professor||Samsung Medical Center|