A phase II study of modified FOLFIRINOX(5-FU/LV, irinotecan and oxaliplatin) as second-line chemotherapy for advanced biliary tract cancer after gemcitabine based chemotherapy failure

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CRIS

Registry ID

KCT0004433

Enrollment

Registered

2019-11-14

Start date

2019-12-01

Completion date

Unknown

Last updated

2021-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : Modified FOLFIRINOX regimen Day 1 • Oxaliplatin 65 mg / m2 / d IV over 90mins • Irinotecan 135 mg / m2 / d IV over 90 minutes after 30 minutes • Leucovorin 400 mg / m2 / d IV over 1hr,

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patients with histologically or cytologically confirmed carcinoma (gallbladder, intrahepatic, extrahepatic bili duct origin) 2) Locally advanced, unresectable or metastatic biliary tract carcinoma not amenable to curative radiotherapy or surgery 3) Previously treated with gemcitabine-based chemotherapy as palliative 1st-line chemotherapy or relapse after gemcitabine-based adjuvant chemotherapy within 6 months 4) Age: 19 -75 years 5) ECOG performance status 0-2 6) No radiotherapy within 1 month of the study entry 7) Measurable or evaluable lesion according to RECIST criteria 8) Adequate marrow, hepatic, renal and cardic function - Absolute neutophil count = 1.5 x 109/L; platelets = 100 x 109/L; - total bilirubin =1.5xUNL( if due to underlying liver metastasis, then total bilirubin may be =3 xUNL); - AST and/or ALT = 3 x UNL; if liver function abnormalities are due to underlying liver metastasis, then AST and/or ALT may be = 5x UNL; - Creatinine = 1.5mg/dl or creatinine clearance =50 ml/min - Ejection fraction = 50% (on echocardiography within 1 year, or if there is no symptom and age = 60, echocardiography is exempted) 9) Controlled biliary obstruction more than 2 weeks 10) Written informed consent must be provided

Exclusion criteria

Exclusion criteria: 1) Locally advanced biliary tract cancer 2) Prior systemic chemotherapy within 3 weeks 3) Peripheral neuropathy more than grade 2 before study enrollment 4) Previously treated with irinotecan and oxaliplatin for the biliary tract cancer 5) Active CNS metastasis not controllable with radiotherapy or corticosteroid - Patients with symptoms suggestive of CNS metastases must undergo radiologic evaluation to rule out metastases - Patients with known, asymptomatic CNS lesions are permitted 6) Known history of hypersensitivity to study drugs 7) Past (=5years) or concurrent history of other neoplasm, except curatively treated basal cell skin cancer or adequately treated in-situ carcinoma of the cervix. 8) Subjects who cannot be regularly followed up for psychological, social, familial or geographic reasons. 9) Pregnant or lactating women 10) Uncontrolled active infection 11) Prior radiation therapy within 1 month

Design outcomes

Primary

Measure	Time frame
Progression free survival	—

Secondary

Measure	Time frame
Response rate, Progression free survival and toxicity evaluation	—

Countries

Korea, Republic of

Contacts

Public ContactJun Ho Ji

Samsung Changwon Medical Center

Outcome results