Neoadjuvant FIRINOX for Borderline Resectable Pancreatic Cancer - a Pilot Study

NCT02148549 | Completed Phase 1 DMC

• 2 other identifiers: FIRINOXUMIN000013809
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 9

Brief Summary

FOLFIRINOX regimen was recently presented at an international oncology meeting and represents a new standard regimen in the treatment of metastatic pancreatic cancer. FOLFIRINOX is one of the high response rate treatment regimen , the investigators considered as a promising treatment as neoadjuvant chemotherapy . On the other hand , incidences of grade 3 or 4 neutropenia , febrile neutropenia and diarrhea were significantly higher in the FOLFIRINOX group compared with gemcitabine group. Therefore, it was decided to consider the balance of safety and efficacy as a preoperative chemotherapy, the investigators use the FIRINOX regimen by eliminating LV and bolus 5-FU, and irinotecan reduced to 150mg/m2 of 180mg/m2 from FOLFIRINOX regimen

Conditions

Patients With Borderline Resectable Pancreatic Cancer

Keywords

Borderline resectable pancreatic cancer; R0 resection; Resection rate; Optimal schedule

Outcome Measures

Primary Outcomes (1)

• Number of participants with toxicity of FIRINOX therapy as neoadjuvant chemotherapy for borderline resectable pancreatic cancer.

  Toxicities will be assessed according to Common Terminology Criteria for Adverse Events (CTCAE) 4.0.

  Up to 30 weeks.

Secondary Outcomes (3)

• The resection rate of FIRINOX therapy as neoadjuvant chemotherapy for borderline resectable pancreatic cancer.

  Up to 24 weeks.

• The R0 resection rate of FIRINOX therapy as neoadjuvant chemotherapy for borderline resectable pancreatic cancer.

  Up to 30 weeks.

• The optimal treatment schedule of FIRINOX therapy as neoadjuvant chemotherapy for borderline resectable pancreatic cancer.

  Up to 2 years.

Study Arms (1)

Optimal chemotherapy courses

EXPERIMENTAL

Neoadjuvant chemotherapy 4 courses of FIRINOX early 5 patients, and 8 courses of FIRINOX subsequent 5 patients

Drug: FIRINOX

Interventions

FIRINOX DRUG

FIRINOX regimen by eliminating LV and bolus 5-FU, and irinotecan reduced to 150mg/m2 of 180mg/m2 from FOLFIRINOX regimen.

Also known as: Oxaliplatin, Irinotecan, 5-FU.

Optimal chemotherapy courses

Eligibility Criteria

• Age: 20 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pathologically proven invasive pancreatic ductal carcinoma
• Cases that meet the definition of borderline resectable pancreatic cancer 1) or 2)
• Definition of a borderline resectable pancreatic cancer is filledin NCCN guideline version 1.2014 pancreatic adenocarcinoma
• Patients indicated distal pancreatectomy with en bloc celiac axis resection
• PS (ECOG) 0-1
• ≧20 years old and \< 75 years old
• First line treatment
• The following criteria must be satisfied in laboratory tests within 14 days of registration White blood cell count ≦12,000/mm3 Neutrophil count ≧1,500/mm3 Platelet count ≧100,000mm3 Total bilirubin \<2.0mg/dL Serum Creatinine ≦upper limits of normal(ULN) AST, ALT≦2.5×ULN Albumin≧3.0g/dL Hemoglobin≧9.0g/dL
• Written informed consent to participate in this study

You may not qualify if:

• Severe drug hypersensitivity
• Multiple primary cancers within 5 years
• Severe infection
• With grade2 or more severe peripheral neuropathy
• With intestinal paralysys, ileus
• Interstitial pneumonia or pulmonary
• With uncontrollable pleural effusion or ascites
• Receiving atazanavir sulfate
• With uncontrollable diabetes
• With uncontrollable heart failure, angina, hypertension, arrhythmia
• With severe psychological symptoms
• With watery diarrhea
• Pregnant or lactating women, or women with known or suspected pregnancy
• Inappropriate patients for entry on this study in the judgment of the investigator
• With UGT1A1\*28 and/or UGT1A1\*6 polymorphisms

Sponsors & Collaborators

• Wakayama Medical University: lead

Study Sites (9)

Nagoya University

Nagoya, Aichi-ken, Japan

Location

Kobe University

Kobe, Hyōgo, Japan

Location

Nara Prefectual Medical University

Kashihara, Nara, Japan

Location

Kansai Medical University

Hirakata, Osaka, Japan

Location

Osaka University

Suita, Osaka, Japan

Location

Hiroshima University

Hiroshima, Japan

Location

Osaka City University

Osaka, Japan

Location

Osaka Medical Center for Cancer and CVD

Osaka, Japan

Location

Wakayama Medical University

Wakayama, 641-8510, Japan

Location

MeSH Terms

Interventions

Oxaliplatin; Irinotecan; Fluorouracil

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Camptothecin; Alkaloids; Heterocyclic Compounds; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Hiroki Yamaue, M.D., PhD

  Wakayama Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dean & Professor

Study Record Dates

• First Submitted: May 15, 2014
• First Posted: May 28, 2014
• Study Start: April 1, 2014
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2017
• Last Updated: October 7, 2019

Record last verified: 2015-07

Locations

JP (9)