Phase II Study of Gemcitabine and TS-1 in Biliary Trat Cancer

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Brief Title

Phase II Study of Gemcitabine and TS-1 in Biliary Trat Cancer

Official Title

A Phase II Study of Gemcitabine and TS-1 in Patients With Previously Untreated Metastatic or Recurrent Biliary Tract Cancer

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. 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 Phase

Phase 2

Study Type

Interventional


Primary Outcome

Response rate


Condition

Biliary Tract Cancer

Intervention

Gemcitabine TS-1

Study Arms / Comparison Groups

 Gemcitabine, Ts-1
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

19

Start Date

February 2008

Completion Date

December 2009

Primary Completion Date

December 2009

Eligibility Criteria

        Inclusion Criteria:

          -  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 Criteria:

          -  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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Yeong Lim Lim, Professor, , 



Administrative Informations


NCT ID

NCT01171755

Organization ID

2007-11-008

Secondary IDs

82-02-3410-0914

Responsible Party

Sponsor

Study Sponsor

Samsung Medical Center


Study Sponsor

Yeong Lim Lim, Professor, Principal Investigator, Samsung Medical Center


Verification Date

January 2012