Phase I Study Of Neoadjuvant Chemotherapy For Patients With Borderline Resectable Pancreatic Cancer.

Study Overview

Phase I Study of Neoadjuvant Chemotherapy for Patients With Borderline Resectable Pancreatic Cancer.

Gemcitabine plus nub-paclitaxel (GEMABR) regimen was recently presented at an international oncology meeting and represents a new standard regimen in the treatment of metastatic pancreatic cancer. Therefore, it was decided to consider the balance of safety and efficacy as a preoperative chemotherapy, the investigators use the NAC-GEMABR regimen includes only two cycles (three times weekly and one week rest) of GEMABR regimen.

Gemcitabine plus nub-paclitaxel (GEMABR) regimen was recently presented at an international oncology meeting and represents a new standard regimen in the treatment of metastatic pancreatic cancer. GEMABR 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 peripheral neuropathy were significantly higher in the g 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 NAC-GEMABR regimen includes only two cycles (three times weekly and one week rest) of GEMABR regimen. The investigators also evaluate the optimal treatment schedule of NAC-GEMABR therapy as neoadjuvant chemotherapy, optimal duration between surgery and chemotherapy, R0 resection rate, and resection rate for borderline resectable pancreatic cancer.

Pancreatic Cancer

DRUG: NAC-GEMABR

NAC-GEMABR

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2015-07-22	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2016-05-11
First Submitted that Met QC Criteria 2015-07-22	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2016-05-12
First Posted (ESTIMATED) 2015-07-23	Results First Posted N/A	Last Verified 2016-05

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: NAC-GEMABR Neoadjuvant chemotherapy 2 courses of NAC-GEMABR for subsequent 10 patients.	DRUG: NAC-GEMABR NAC-GEMABR regimen includes gemcitabine 1000mg/m2 plus nab-paclitaxel 125mg/m2 3 times weekly 1week rest.

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: NAC-GEMABR

Neoadjuvant chemotherapy 2 courses of NAC-GEMABR for subsequent 10 patients.

DRUG: NAC-GEMABR

NAC-GEMABR regimen includes gemcitabine 1000mg/m2 plus nab-paclitaxel 125mg/m2 3 times weekly 1week rest.

Primary Outcome Measures	Measure Description	Time Frame
Number of participants with toxicity of NAC-GEMABR 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 Outcome Measures	Measure Description	Time Frame
The resection rate of NAC-GEMABR therapy as neoadjuvant chemothterapy for borderline resectable pancreatic cancer.		Up to 24 weeks
The R0 resection rate of NAC-GEMABR therapy as neoadjuvant chemotherapy for borderline resectable pancreatic cancer.		Up to 30 weeks

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Hiroki Yamaue, M.D., PhD

Phone Number: +81-73-441-0613

Email: yamaue-h@wakayama-med.ac.jp

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
20 Years

Accepts Healthy Volunteers:

Pathologically proven invasive pancreatic ductal carcinoma
Cases that meet the definition of borderline resectable pancreatic cancer 1) or 2)

PS (ECOG) 0-1
≧20 years old and < 80 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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Hiroki Yamaue, M.D., PhD, Wakayama Medical University

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Okada KI, Hirono S, Kawai M, Miyazawa M, Shimizu A, Kitahata Y, Ueno M, Hayami S, Yamaue H. Phase I Study of Nab-Paclitaxel plus Gemcitabine as Neoadjuvant Therapy for Borderline Resectable Pancreatic Cancer. Anticancer Res. 2017 Feb;37(2):853-858. doi: 10.21873/anticanres.11389.

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Clinical Trial Record