mFOLFOX vs. mFOLFIRI in Advanced or Recurrent Biliary Tract Cancer Refractory to First Line

Seoul National University

Status and phase: Completed; Phase 2

Conditions: Biliary Cancer Metastatic

Treatments: Drug: Oxaliplatin,5FU, leucovorin; Drug: irinotecan,5FU, leucovorin

Study type: Interventional

Funder types: Other

Identifiers

NCT03464968

biliary second line

Details and patient eligibility

About

In second line with advanced or recurrent biliary tract cancer refractory to first line gemcitabine plus cisplatin, efficacy of mFOLFOX vs. mFOLFIRI will be evaluated at randomized phase 2 trial.

Full description

1. brief enrollment criteria

   • histological confirmed
   • refractory to first line gemcitabine plus cisplatin
   • fit for chemotherapy

2. treatment arms A. mFOLFOX D1 oxaliplatin 100mg/m2 over 2hr Leucovorin 100mg/m2 over 2hr 5FU 2400mg/m2 over 46hr Every 2 weeks

   B. mFOLFIRI D1 Irinotecan 150mg/m2 over 2hr Leucovorin 100mg/m2 over 2hr 5FU 2400mg/m2 over 46hr Every 2 weeks

3. randomization - stratified by tumor site and performance status

Enrollment: 120 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 20 years and older
• pathologically confirmed biliary tract cancer (adenocarcinoma) including intrahepatic, extrahepatic, gallbladder, ampulla of vater
• initially inoperable or recurrent
• ECOG 0-2
• as first line chemotherapy, refractory to gemcitabine/cisplatin (at least one cycle applied)
• evaluable or measurable lesion
• within 1 week, patients who meet below laboratory results (hemoglobin >9.0 g/dL, neutrophil >1000/uL, platelet> 75000/uL, serum creatinine < UNL * 1.5, AST/ALT < UNL*3, total bilirubin < UNL*1.5 (available for biliary drainage)
• patients who have ability to understand the purpose, benefit and harm for this trial, and the right to withdraw this trial in any time without any disadvantage

Exclusion criteria

• other cancer history
• pregnant or lactating
• uncontrolled medical condition such as infection or cardiovascular disease
• hypersensitivity to experimental drugs
• uncontrolled CNS metastasis, psychologic problem

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

mFOLFOX

Experimental group

Description:

D1 oxaliplatin 100mg/m2 over 2hr Leucovorin 100mg/m2 over 2hr 5FU 2400mg/m2 over 46hr Every 2 weeks

Treatment:

Drug: Oxaliplatin,5FU, leucovorin

mFOLFIRI

Experimental group

Description:

D1 Irinotecan 150mg/m2 over 2hr Leucovorin 100mg/m2 over 2hr 5FU 2400mg/m2 over 46hr Every 2 weeks

Treatment:

Drug: irinotecan,5FU, leucovorin