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

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: Pancreatic Cancer
• Intervention / Treatment: Drug: Gemcitabine; Drug: Nab-Paclitaxel

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

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

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	1 years

Secondary Outcome Measures

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

Collaborators and Investigators

• 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

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: Digestive System Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Gemcitabine; Paclitaxel; Albumin-Bound Paclitaxel
• Other Study ID Numbers: TatsuyaIoka2013; UMIN 000012254 (Registry Identifier: UMIN)