Phase I Study of Neoadjuvant Chemotherapy for Patients With Borderline Resectable Pancreatic Cancer.

• Status: Unknown status
• Trial end date: 2017-06-01
• Target enrollment: 0
• Participant gender: All

Summary

Gemcitabine plus nub-paclitaxel (GEMABR) regimen was recently presented at an international oncology meeting and represents a new standard regimen in the treatment of metastatic pancreatic cancer. Therefore, it was decided to consider the balance of safety and efficacy as a preoperative chemotherapy, the investigators use the NAC-GEMABR regimen includes only two cycles (three times weekly and one week rest) of GEMABR regimen.

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

Details

• Lead Sponsor: Wakayama Medical University
• Treatments: Albumin-Bound Paclitaxel; Gemcitabine; Paclitaxel

Criteria

Inclusion Criteria:

• Pathologically proven invasive pancreatic ductal carcinoma

• Cases that meet the definition of borderline resectable pancreatic cancer 1) or 2)

1. Definition of a borderline resectable pancreatic cancer is filledin NCCN guideline version 1.2014 pancreatic adenocarcinoma

2. Patients indicated distal pancreatectomy with en bloc celiac axis resection

• PS (ECOG) 0-1

• ≧20 years old and < 80 years old

• First line treatment

• The following criteria must be satisfied in laboratory tests within 14 days of registration White blood cell count ≦12,000/mm3 Neutrophil count ≧1,500/mm3 Platelet count ≧100,000mm3 Total bilirubin <2.0mg/dL Serum Creatinine ≦upper limits of normal(ULN) AST, ALT≦2.5×ULN Albumin≧3.0g/dL Hemoglobin≧9.0g/dL

• Written informed consent to participate in this study

Exclusion Criteria:

• Severe drug hypersensitivity

• Multiple primary cancers within 5 years

• Severe infection

• With grade2 or more severe peripheral neuropathy

• With intestinal paralysys, ileus

• Interstitial pneumonia or pulmonary

• With uncontrollable pleural effusion or ascites

• Receiving atazanavir sulfate

• With uncontrollable diabetes

• With uncontrollable heart failure, angina, hypertension, arrhythmia

• With severe psychological symptoms

• With watery diarrhea

• Pregnant or lactating women, or women with known or suspected pregnancy

• Inappropriate patients for entry on this study in the judgment of the investigator