Status:
TERMINATED
Phase II Study of Gemcitabine and TS-1 in Biliary Trat Cancer
Lead Sponsor:
Samsung Medical Center
Conditions:
Biliary Tract Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
In current study, we evaluate the efficacy of gemcitabine and TS-1 combination chemotherapy in advanced BTC.
Detailed Description
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. Becau...
Eligibility Criteria
Inclusion
- 1\. Pathologically proven, measurable, unresectable, locally advanced or metastatic adenocarcinoma arising from the intra- and extrahepatic biliary ducts or gallbladder or papilla of Vater 2. No prior chemotherapy for advanced disease was allowed 3. No concurrent radiotherapy 4. At least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST) 5. At least 18 years old 6. ECOG performance status of ≤ 2 7. Adequate organ function as evidenced by the following; Absolute neutophil count \> 1.5 x 109/L; platelets \> 100 x 109/L; hemoglobin \> 10g/dL; INR ≤ 1.4; total bilirubin ≤1.5 UNL; AST and/or ALT \< 5 UNL; albumin \> 3g/dL or \> 30µmol/L; creatinine clearance ≥ 50mL/minInformed consent signed 8. Subject able to comply with the scheduled follow-up and the management of toxicities
Exclusion
- 1\. Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of TS-1 (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or small bowel resection) 2. Subject with reproductive potential (male or female) not using adequate contraceptive measures 3. Pregnancy and breast-feeding 4. Other serious illness or medical condition, notably heart or lung failure, active uncontrolled infection (infection requiring antibiotics) 5. History of significant cardiac disease, arrhythmias and angina pectoris 6. Past or concurrent history of other neoplasm, except curatively treated basal cell skin cancer or adequately treated in-situ carcinoma of the cervix 7. Other concomitant anticancer agent 8. Subjects who cannot be regularly followed up for psychological, social, familial or geographic reasons 9. Patients who are using other investigational agents or who had received investigational drugs ≤ 4 weeks prior to first study treatment
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT01171755
Start Date
February 1 2008
End Date
December 1 2009
Last Update
May 21 2014
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