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

Primary Purpose

Pancreatic Cancer

Status
Completed
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
Gemcitabine
Nab-Paclitaxel
Sponsored by
Osaka Medical Center for Cancer and Cardiovascular Diseases
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Cancer

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Osaka Medical Center for Cancer and Cardiovascular Diseases

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Gemcitabine, Nab-Paclitaxel

Arm Description

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.

Outcomes

Primary Outcome Measures

Number of patients with Adverse Events

Secondary Outcome Measures

Response Rate
Overall Survival time

Full Information

First Posted
October 18, 2014
Last Updated
November 19, 2017
Sponsor
Osaka Medical Center for Cancer and Cardiovascular Diseases
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1. Study Identification

Unique Protocol Identification Number
NCT02272738
Brief Title
A Study of Chemoradiotherapy Using Gem Plus Nab-paclitaxel for Pancreatic Cancer
Official Title
A Phase I Study of Chemoradiotherapy Using Gemcitabine Plus Nab-paclitaxel for Unresectable Locally Advanced Pancreatic Adenocarcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
August 2013 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Osaka Medical Center for Cancer and Cardiovascular Diseases

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Gemcitabine, Nab-Paclitaxel
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Other Intervention Name(s)
Gemcitabine ；gemzer
Intervention Description
Gemcitabine is administered with 30 min intravenous infusion on day 1,8 and 15 every 4 weeks.
Intervention Type
Drug
Intervention Name(s)
Nab-Paclitaxel
Other Intervention Name(s)
Nab-Paclitaxel ；Abraxane
Intervention Description
Nab-Paclitaxel is administered with 30 min intravenous infusion on day 1,8 and 15 every 4 weeks.
Primary Outcome Measure Information:
Title
Number of patients with Adverse Events
Time Frame
1 years
Secondary Outcome Measure Information:
Title
Response Rate
Time Frame
1 years
Title
Overall Survival time
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tatsuya Ioka, MD
Organizational Affiliation
Osaka Medical Center for Cancer and Cardiovascular Diseases
Official's Role
Study Director
Facility Information:
Facility Name
Osaka Medical Center for Cancer and Cardiovascular Diseases
City
Osaka
ZIP/Postal Code
537-8511
Country
Japan

12. IPD Sharing Statement

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

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