FOLFIRI as Salvage Treatment in Metastatic Biliary Tract Cancer (BTC) Patients Who Were Failed After Gemcitabine Containing Chemotherapy: A Phase II Single Arm Prospective Study

Brief Title

FOLFIRI as Salvage Treatment in Metastatic Biliary Tract Cancer (BTC) Patients Who Were Failed After Gemcitabine Containing Chemotherapy: A Phase II Single Arm Prospective Study

Official Title

SAMSUNG MEDICAL CENTER

Brief Summary

      FOLFIRI as a salvage treatment in metastatic biliary tract cancer (BTC) patients who failed
      gemcitabine containing chemotherapy
    

Detailed Description

      Biliary tract carcinoma (BTC) is rare in the Europe and the United States, but not uncommon
      in Asia and Latin America. The tumor arises from the ductular epithelium of the biliary tree
      within the liver (intrahepatic), the extrahepatic ducts (extrahepatic), or the gallbladder.
      Intrahepatic cancer is steadily increasing in the Western world. BTCs carry a poor prognosis
      with 1-year survival rate of 25%. Although surgery remains the only curative treatment for
      BTC, most patients present with advanced disease and die within a few months of diagnosis.
      While a combination of gemcitabine and platinum agents seems to be a conclusive treatment
      option as first-line treatment until now, the role or the optimal regimen for second-line
      treatment has not been established.

      Few articles about second line treatment in advanced BTC were reported. French group recently
      reported the retrospective analysis of FOLFIRI regimen in advanced BTC patients. However,
      there is no prospective trial of FOLFIRI regimen to evaluate the efficacy and safety in
      advanced BTC patients.

      So we plan this study to evaluate the efficacy and safety of FOLFIRI regimen as a second line
      treatment in biliary tract cancer.
    

Study Phase

Phase 2

Study Type

Interventional

Primary Outcome

Overall Overall Response Rate

Secondary Outcome

 Progression-free survival

Condition

Biliary Tract Cancer

Intervention

Fluorouracil

Study Arms / Comparison Groups

 FOLFIRI

Description:  D1 Irinotecan 180 mg/m2 IV D1-2 5-FU 400mg/m2 bolus and then 2400mg/m2 continuous infusion D1 Leucovorin 200 mg/m2 Until disease progression, patient's refusal or unacceptable toxicities

Publications

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

Recruitment Status

Drug

Estimated Enrollment

38

Start Date

June 2020

Completion Date

December 2021

Primary Completion Date

December 2021

Eligibility Criteria

        Inclusion Criteria:

        Provision of a signed written informed consent Age ≥ 20 Histologically or cytologically
        confirmed carcinoma of biliary tract Progression after treatment with first line
        gemcitabine-based chemotherapy ECOG performance status of 0~2 Measurable lesion per RECIST
        1.1 criteria Expected life expectancy ≥ 3months Adequate marrow, hepatic, renal and cardiac
        functions Negative pregnancy test within 28 days Available archival tissue or fresh biopsy

        Exclusion Criteria:

        Poor performance statue Previous treatment history of irinotecan Hypersensitivity to
        irinotecan Other primary cancer except properly treated non-melanoma skin cancer, cured
        cervix carcinoma in situ and other cured solid tumor without evidence of recurrence after 5
        years of curative treatment.

        Severe co-morbid illness and/or active infections Any other clinical trial therapeutics
        within 14 days Any anti-cancer therapy within 3 weeks prior to initiation of study
        treatment (radiotherapy, systemic chemotherapy) CTCAE grade 2 or more adverse events
        remained Intestinal obstruction or CTCAE grade 3-4 upper GI bleeding within 4 weeks QTcB >
        480msec or family history of QT prolongation Current heart problem such as: pooly
        controlled hypertension cardiomyopathy, clinically significant valvular heart disease,
        uncontrolled angina, acute coronary syndrome within 6 months.

        Severe, uncontrolled systemic disease, active infection such as HBV, HCV or HIV, active
        bleeding tendency or history of organ transplantation
      

Gender

All

Ages

20 Years - N/A

Accepts Healthy Volunteers

No

Contacts

joonoh park, 82-2-3410-6820, [email protected]

Location Countries

Korea, Republic of

Location Countries

Korea, Republic of

NCT ID

NCT03110510

Organization ID

2017-02-094

Responsible Party

Principal Investigator

Study Sponsor

Samsung Medical Center

Study Sponsor

joonoh park, Principal Investigator, SamsungMedicalCenter

Verification Date

May 2019