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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02272738
Recruitment Status : Completed
First Posted : October 23, 2014
Last Update Posted : November 21, 2017
Sponsor:
Information provided by (Responsible Party):
Osaka Medical Center for Cancer and Cardiovascular Diseases

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.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Drug: Gemcitabine Drug: Nab-Paclitaxel Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Study of Chemoradiotherapy Using Gemcitabine Plus Nab-paclitaxel for Unresectable Locally Advanced Pancreatic Adenocarcinoma
Study Start Date : August 2013
Actual Primary Completion Date : November 2015
Actual Study Completion Date : April 2016


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 Name: Gemcitabine ;gemzer

Drug: Nab-Paclitaxel
Nab-Paclitaxel is administered with 30 min intravenous infusion on day 1,8 and 15 every 4 weeks.
Other Name: Nab-Paclitaxel ;Abraxane




Primary Outcome Measures :
  1. Number of patients with Adverse Events [ Time Frame: 1 years ]

Secondary Outcome Measures :
  1. Response Rate [ Time Frame: 1 years ]
  2. Overall Survival time [ Time Frame: 2 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02272738


Locations
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Japan
Osaka Medical Center for Cancer and Cardiovascular Diseases
Osaka, Japan, 537-8511
Sponsors and Collaborators
Osaka Medical Center for Cancer and Cardiovascular Diseases
Investigators
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Study Director: Tatsuya Ioka, MD Osaka Medical Center for Cancer and Cardiovascular Diseases

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Responsible Party: Osaka Medical Center for Cancer and Cardiovascular Diseases
ClinicalTrials.gov Identifier: NCT02272738    
Other Study ID Numbers: TatsuyaIoka2013
UMIN 000012254 ( Registry Identifier: UMIN )
First Posted: October 23, 2014    Key Record Dates
Last Update Posted: November 21, 2017
Last Verified: November 2017
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gemcitabine
Paclitaxel
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs