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

• Status: Completed
• Trial end date: 2016-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Osaka Medical Center for Cancer and Cardiovascular Diseases
• Treatments: Albumin-Bound Paclitaxel; Gemcitabine; Paclitaxel

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