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Completed

NCT Number: NCT02272738

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

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.

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Key information

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Osaka Medical Center for Cancer and Cardiovascular Diseases

Osaka, 537-8511, Japan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gemcitabine

Drug

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

Other names: Gemcitabine ;gemzer

Nab-paclitaxel

Drug

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

Other names: Nab-Paclitaxel ;Abraxane

Primary outcomes

  1. Number of patients with Adverse Events

    Time frame: 1 years

Secondary outcomes

  1. Response Rate

    Time frame: 1 years

  2. Overall Survival time

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Osaka Medical Center for Cancer and Cardiovascular Diseases

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2016
First posted
Oct 23, 2014
Registry last updated
Nov 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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