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

Sponsor
Samsung Medical Center
Study ID
NCT03110510
Phase
PHASE2
Status
Withdrawn

Conditions

  • Biliary Tract Cancer

Eligibility Criteria

Sex
ALL
Age
20 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Fluorouracil — DRUG
    5FU 400mg/m2 bolus and then 2400mg/m2, continuous infusion D1-2
  • Irinotecan Hydrochloride — DRUG
    Irinotecan 180 mg/m2
  • leucovorin calcium — DRUG
    Leucovorin 200 mg/m2

Study Details

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

Key Dates

Start date
Sep 6, 2019
Status verified
Jun 2022
Primary completion
Sep 6, 2019
Completion
Sep 6, 2019

Study Design

Enrollment
0 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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

Primary Outcome Measure

Overall Overall Response Rate [ Time Frame: 15 months ]

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