Phase I study of third-line FOLFIRINOX (oxaliplatin, irinotecan, 5-FU, and leucovorin) unresectable Gem/S-1 refractory pancreatic adenocarcinoma

Phase I study of third-line FOLFIRINOX (oxaliplatin, irinotecan, 5-FU, and leucovorin) unresectable Gem/S-1 refractory pancreatic adenocarcinoma - Phase I study of third-line FOLFIRINOX for pancreatic adenocarcinoma

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000021526

Enrollment

Registered

2016-03-18

Start date

2014-03-01

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

unresectable Gem/S-1 refractory pancreatic adenocarcinoma

Interventions

This dose-escalation study was conducted as a phase I trial with a 3+3 design to estimate MTD of third-line FOLFIRINOX. Level1(L-OHP 55mg/m2, CPT-11 75mg/m2, 5FU 1200mg/m2 ) Level2(L-OHP 55mg/m2

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Histologically or cytologically confirmed locally advanced or metastatic pancreatic adenocarcinoma 2. Performance Status 0-1 (ECOG) 3. WBC <=12,000/mm3 Neutrophils >=1,500/mm3 Platelets >=100,000/mm3 Hemoglobin >=9.0g/dL GOT, GPT: less than 3-fold of the upper limit of normal range Total bilirubin <3.0mg/dL Albumin >=3.5g/dL Creatinine clearance >=50ml/min 4. Life expectancy of at least 3 months 5. Written informed consent

Exclusion criteria

Exclusion criteria: 1. Poorly controlled ascites 2. Patients homozygous for UGT1A1*6 or UGT1A1*28, or double heterozygotes (*6/*28) 3. Active infection 4. Lung fibrosis or intestinal pneumonia detectable on chest X-ray and CT 5. Severe complication (heart disease, cirrhosis, diabetes) 6. Myocardial infarction within 3 months 7. Active synchronous or metachronous malignancy, excluding intramucosal carcinoma 8. Pregnant or lactation women, or women with known or suspected pregnancy 9. Symptomatic brain metastasis 10. history of severe drug allergy 11. Grade 2 or higher peripheral sensory neuropathy 12. Impossible to implant the central venous port 13.Patients who are judged inappropriate for the entry into the study by the investigator

Design outcomes

Primary

Measure	Time frame
occurrence of side effect of preoperative gemcitabine based chemoradiation therapy	—

Secondary

Measure	Time frame
Response Rate, Overall Survival (OS) , Progression free survival (PFS)	—

Countries

Japan

Contacts

Public ContactTatsuya Ioka

Osaka Medical Center for Cancer and Cardiovascular Diseases Division of Hepatobiliary and Pancreatic Oncology

ioka-ta@mc.pref.osaka.jp06-6972-1181

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026