A Study of Chemoradiotherapy Using Gem Plus Nab-paclitaxel for Pancreatic Cancer

November 19, 2017 updated by: Osaka Medical Center for Cancer and Cardiovascular Diseases

A Phase I Study of Chemoradiotherapy Using Gemcitabine Plus Nab-paclitaxel for Unresectable Locally Advanced Pancreatic Adenocarcinoma

The purpose of this study is to evaluate the clinical safety and efficacy of Gemcitabine plus nab-Paclitaxel chemoradiotherapy and to determine the Maximal Tolerated Dose (MTD) for unresectable locally advanced pancreatic adenocarcinoma.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Gemcitabine plus nab-Paclitaxel is one of the standard chemotherapy for metastatic pancreatic adenocarcinoma. Gemcitabine plus nab-Paclitaxel realize the favorable anti-tumor effect and tolerable toxicity. Gemcitabine plus nab-Paclitaxel is a promising regimen for concurrent chemoradiotherapy, but the investigators need to know the safety in the case of the concurrent chemoradiotherapy.

Study Type

Interventional

Enrollment (Actual)

54

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
      • Osaka, Japan, 537-8511
        • Osaka Medical Center for Cancer and Cardiovascular Diseases

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

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Histologically or cytologically confirmed advanced pancreatic cancer
  • Locally advanced pancreatic cancer is defined as the presence of a surgically unresectable tumor(involving the celiac axis or the superior mesenteric artery)
  • Performance Status:0-1(ECOG)
  • Patients of age =>20 and 75>

  • White Blood Cell (WBC) >=3,500/mm3,12,000/mm3,

    • Neutrophils >=1,500/mm3, platelets=100,000/mm3,
    • Hemoglobin >=9.5 g/dl,
    • GOT </=2.0 X Upper Limit Number (ULN),
    • Glutamate Pyruvate Transaminase (GPT) </=2.0 X ULN,
    • Alkaline Phosphatase (ALP) </=2.0 X ULN,
    • Total bilirubin <=1.5mg/dl,
    • Serum creatinine <=1.2mg/dl,
    • Creatinine clearance>=50 ml/min
    • arterial O2 pressure (PaO2) >=70torr or arterial O2 saturation (SpO2) >=96%
  • Life expectancy more than 3 months.
  • Written informed consent.

Exclusion Criteria:

  • Active infection
  • Lung fibrosis or intestinal pneumonia detectable on chest X-ray and CT
  • Severe complication (heart disease, cirrhosis, diabetes)
  • Myocardial infarction within 3 months
  • Active synchronous or metachronous malignancy
  • Pregnant or lactation women, or women with known or suspected pregnancy
  • Symptomatic brain metastasis
  • History of severe drug allergy
  • Peripheral neuropathy
  • Patients who are judged inappropriate for the entry into the study by 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: Gemcitabine, Nab-Paclitaxel

A conformal phase I study using 3 plus 3 method.

Chemoradiotherapy while Gemcitabine, Nab-Paclitaxel are administered.

Both Gemcitabine and Nab-Paclitaxel are an interventional agents in this arm.

Gemcitabine is administered with 30 min intravenous infusion on day 1,8 and 15 every 4 weeks.

Nab-Paclitaxel is administered with 30 min intravenous infusion on day 1,8 and 15 every 4 weeks.

Radiotherapy (a total dose of 50.4Gy) was delivered in 28 fractions.
Drug: Gemcitabine
Gemcitabine is administered with 30 min intravenous infusion on day 1,8 and 15 every 4 weeks.
Other Names:
  • Gemcitabine ；gemzer
Drug: Nab-Paclitaxel
Nab-Paclitaxel is administered with 30 min intravenous infusion on day 1,8 and 15 every 4 weeks.
Other Names:
  • Nab-Paclitaxel ；Abraxane

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of patients with Adverse Events
Time Frame: 1 years
1 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Response Rate
Time Frame: 1 years
1 years
Overall Survival time
Time Frame: 2 years
2 years

Collaborators and Investigators

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

Sponsor

Osaka Medical Center for Cancer and Cardiovascular Diseases

Investigators

  • Study Director: Tatsuya Ioka, MD, Osaka Medical Center for Cancer and Cardiovascular Diseases

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

August 1, 2013

Primary Completion (Actual)

November 1, 2015

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

October 18, 2014

First Submitted That Met QC Criteria

October 22, 2014

First Posted (Estimate)

October 23, 2014

Study Record Updates

Last Update Posted (Actual)

November 21, 2017

Last Update Submitted That Met QC Criteria

November 19, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TatsuyaIoka2013
  • UMIN 000012254 (Registry Identifier: UMIN)

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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