A Study of Chemoradiotherapy Using Gem Plus Nab-paclitaxel for Pancreatic Cancer
Conditions
Pancreatic Cancer
Conditions: official terms
Pancreatic Neoplasms
Study Type
Interventional
Study Phase
Phase 1
Study Design
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Gemcitabine Type: Drug
Name: Nab-Paclitaxel Type: Drug
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 75 Years
Minimum Age: 20 Years
Gender: Both
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
- Glutamate Pyruvate Transaminase (GPT)
- Alkaline Phosphatase (ALP)
- 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
Location
Osaka Medical Center for Cancer and Cardiovascular Diseases
Osaka, Japan
Status: Recruiting
Contact: Tatsuya Ioka - +81-6-6972-1181 - ioka-ta@mc.pref.osaka.jp
Start Date
August 2013
Completion Date
April 2016
Sponsors
Osaka Medical Center for Cancer and Cardiovascular Diseases
Source
Osaka Medical Center for Cancer and Cardiovascular Diseases
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page