NCT02272738

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P50-P75 for phase_1 pancreatic-cancer

Timeline
Completed

Started Aug 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

October 18, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 23, 2014

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

November 21, 2017

Status Verified

November 1, 2017

Enrollment Period

2.3 years

First QC Date

October 18, 2014

Last Update Submit

November 19, 2017

Conditions

Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

  • Number of patients with Adverse Events

    1 years

Secondary Outcomes (2)

  • Response Rate

    1 years

  • Overall Survival time

    2 years

Study Arms (1)

Gemcitabine, Nab-Paclitaxel

EXPERIMENTAL

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: GemcitabineDrug: Nab-Paclitaxel

Interventions

GemcitabineDRUG

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

Also known as: Gemcitabine ；gemzer
Gemcitabine, Nab-Paclitaxel
Nab-PaclitaxelDRUG

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

Also known as: Nab-Paclitaxel ；Abraxane
Gemcitabine, Nab-Paclitaxel

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • +1 more criteria

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Osaka Medical Center for Cancer and Cardiovascular Diseases

Osaka, 537-8511, Japan

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Gemcitabine130-nm albumin-bound paclitaxel

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Tatsuya Ioka, MD

    Osaka Medical Center for Cancer and Cardiovascular Diseases

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 18, 2014

First Posted

October 23, 2014

Study Start

August 1, 2013

Primary Completion

November 1, 2015

Study Completion

April 1, 2016

Last Updated

November 21, 2017

Record last verified: 2017-11

Locations

JP(1)