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

May 11, 2016 updated by: Hiroki Yamaue, Wakayama Medical University

Phase I Study of Neoadjuvant Chemotherapy of Gemcitabine Plus Nab-paclitaxel 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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Phase 1

Contacts and Locations

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

Study Locations

  • Japan
      • Wakayama, Japan, 641-8510
        • Recruiting
        • Wakayama Medical University
        • Principal Investigator:
          • Hiroki Yamaue, M.D., PhD
        • Sub-Investigator:
          • Ken-ichi Okada, M.D., PhD
        • Sub-Investigator:
          • Manabu Kawai, M.D., PhD
        • Sub-Investigator:
          • Seiko Hirono, M.D., PhD
        • Sub-Investigator:
          • Motoki Miyazawa, M.D., PhD
        • Sub-Investigator:
          • Atsushi Shimizu, M.D., PhD
        • Sub-Investigator:
          • Yuji Kitahata, M.D., PhD

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.

Eligibility Criteria

Ages Eligible for Study

16 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Pathologically proven invasive pancreatic ductal carcinoma

  • Cases that meet the definition of borderline resectable pancreatic cancer 1) or 2)

    1. Definition of a borderline resectable pancreatic cancer is filledin NCCN guideline version 1.2014 pancreatic adenocarcinoma
    2. Patients indicated distal pancreatectomy with en bloc celiac axis resection
  • 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

Exclusion Criteria:

  • 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

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

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.
Other Names:
  • Gemcitabine, nab-paclitaxel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with toxicity of NAC-GEMABR therapy as neoadjuvant chemotherapy for borderline resectable pancreatic cancer.
Time Frame: Up to 30 weeks.
Toxicities will be assessed according to Common Terminology Criteria for Adverse Events (CTCAE) 4.0.
Up to 30 weeks.

Secondary Outcome Measures

Outcome Measure
Time Frame
The resection rate of NAC-GEMABR therapy as neoadjuvant chemothterapy for borderline resectable pancreatic cancer.
Time Frame: Up to 24 weeks
Up to 24 weeks
The R0 resection rate of NAC-GEMABR therapy as neoadjuvant chemotherapy for borderline resectable pancreatic cancer.
Time Frame: Up to 30 weeks
Up to 30 weeks

Collaborators and Investigators

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

Sponsor

Wakayama Medical University

Investigators

  • Principal Investigator: Hiroki Yamaue, M.D., PhD, Wakayama Medical University

Publications and helpful links

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

General Publications

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 Major Dates

Study Start

July 1, 2015

Primary Completion (Anticipated)

June 1, 2017

Study Completion (Anticipated)

June 1, 2017

Study Registration Dates

First Submitted

July 22, 2015

First Submitted That Met QC Criteria

July 22, 2015

First Posted (Estimate)

July 23, 2015

Study Record Updates

Last Update Posted (Estimate)

May 12, 2016

Last Update Submitted That Met QC Criteria

May 11, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NAC-GEMABR

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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