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

Phase 1

Completed

• Conditions: Pancreatic Cancer
• Interventions: Drug: Gemcitabine; Drug: Nab-Paclitaxel

• Registration Number: NCT02272738
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2013-08
• Study First Submitted: 2014-10-18
• Study First Submitted QC: 2014-10-22
• Study First Posted: 2014-10-23
• Primary Completion: 2015-11
• Study Completion: 2016-04
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-19
• Last Update Posted: 2017-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Gemcitabine, Nab-Paclitaxel	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.
Gemcitabine, Nab-Paclitaxel	Gemcitabine	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.

Primary Outcome Measures

Name	Time	Method
Number of patients with Adverse Events	1 years

Secondary Outcome Measures

Name	Time	Method
Overall Survival time	2 years
Response Rate	1 years

Trial Locations

Locations (1)

Osaka Medical Center for Cancer and Cardiovascular Diseases; 🇯🇵 Osaka, Japan