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

Pancreatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02272738
• Other study ID #: TatsuyaIoka2013
• Secondary ID: UMIN 000012254
• Status: Completed
• Phase: Phase 1
• First received: October 18, 2014
• Last updated: November 19, 2017
• Start date: August 2013
• Est. completion date: April 2016

Study information

• Verified date: November 2017
• Source: Osaka Medical Center for Cancer and Cardiovascular Diseases
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: April 2016
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
Japan	Osaka Medical Center for Cancer and Cardiovascular Diseases	Osaka

Sponsors (1)

Lead Sponsor	Collaborator
Osaka Medical Center for Cancer and Cardiovascular Diseases

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with Adverse Events		1 years
Secondary	Response Rate		1 years
Secondary	Overall Survival time		2 years