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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03110510
Recruitment Status : Not yet recruiting
First Posted : April 12, 2017
Last Update Posted : May 20, 2019
Information provided by (Responsible Party):
Joon Oh Park, Samsung Medical Center

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

Condition or disease Intervention/treatment Phase
Biliary Tract Cancer Drug: Fluorouracil Drug: Irinotecan Hydrochloride Drug: leucovorin calcium Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 38 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model 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 Every 2 weeks
Masking: None (Open Label)
Primary Purpose: Treatment
Estimated Study Start Date : June 2020
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: FOLFIRI
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
Drug: Fluorouracil
5FU 400mg/m2 bolus and then 2400mg/m2, continuous infusion D1-2
Other Name: Adrucil

Drug: Irinotecan Hydrochloride
Irinotecan 180 mg/m2

Drug: leucovorin calcium
Leucovorin 200 mg/m2

Primary Outcome Measures :
  1. Overall Overall Response Rate [ Time Frame: 15 months ]

Secondary Outcome Measures :
  1. Progression-free survival [ Time Frame: 24 months ]
  2. Overall survival [ Time Frame: 24 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT03110510

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Contact: joonoh park, MD,PhD 82-2-3410-6820

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Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Sponsors and Collaborators
Samsung Medical Center
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Principal Investigator: joonoh park SamsungMedicalCenter
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Responsible Party: Joon Oh Park, professor, Samsung Medical Center Identifier: NCT03110510    
Other Study ID Numbers: 2017-02-094
First Posted: April 12, 2017    Key Record Dates
Last Update Posted: May 20, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Biliary Tract Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Biliary Tract Diseases
Digestive System Diseases
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Protective Agents
Vitamin B Complex
Growth Substances