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

NCT ID: NCT03110510

Last Updated: 2022-06-15

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-06
• Study Completion Date: 2019-09-06

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.

Conditions

Biliary Tract Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Fluorouracil

Intervention Type: DRUG

5FU 400mg/m2 bolus and then 2400mg/m2, continuous infusion D1-2

Irinotecan Hydrochloride

Intervention Type: DRUG

Irinotecan 180 mg/m2

leucovorin calcium

Intervention Type: DRUG

Leucovorin 200 mg/m2

Interventions

Fluorouracil

5FU 400mg/m2 bolus and then 2400mg/m2, continuous infusion D1-2

Intervention Type: DRUG

Irinotecan Hydrochloride

Irinotecan 180 mg/m2

Intervention Type: DRUG

leucovorin calcium

Leucovorin 200 mg/m2

Intervention Type: DRUG

Other Intervention Names

Adrucil

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Samsung Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Joon Oh Park

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

joonoh park

Role: PRINCIPAL_INVESTIGATOR

SamsungMedicalCenter

Locations

Samsung Medical Center

Seoul, , South Korea

Countries

South Korea

Other Identifiers

2017-02-094

Identifier Type: -

Identifier Source: org_study_id