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

Wakayama Medical University

Status and phase

Unknown

Phase 1

Conditions

Pancreatic Cancer

Treatments

Drug: NAC-GEMABR

Study type

Interventional

Funder types

Other

Identifiers

NCT02506803

NAC-GEMABR

Details and patient eligibility

About

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.

Full description

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. GEMABR is one of the high response rate treatment regimen, the investigators considered as a promising treatment as neoadjuvant chemotherapy . On the other hand , incidences of grade 3 or 4 neutropenia , febrile neutropenia and peripheral neuropathy were significantly higher in the g group compared with gemcitabine group. 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. The investigators also evaluate the optimal treatment schedule of NAC-GEMABR therapy as neoadjuvant chemotherapy, optimal duration between surgery and chemotherapy, R0 resection rate, and resection rate for borderline resectable pancreatic cancer.

Enrollment

10 estimated patients

Sex

All

Ages

20 to 79 years old

Volunteers

No Healthy Volunteers

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