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

Phase 1

• Conditions: Pancreatic Cancer
• Interventions: Drug: NAC-GEMABR

• Registration Number: NCT02506803
• Lead Sponsor: Wakayama Medical University

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2015-07
• Study First Submitted: 2015-07-22
• Study First Submitted QC: 2015-07-22
• Study First Posted: 2015-07-23
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-11
• Last Update Posted: 2016-05-12
• Primary Completion: 2017-06
• Study Completion: 2017-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
NAC-GEMABR	NAC-GEMABR	Neoadjuvant chemotherapy 2 courses of NAC-GEMABR for subsequent 10 patients.

Primary Outcome Measures

Name	Time	Method
Number of participants with toxicity of NAC-GEMABR therapy as neoadjuvant chemotherapy for borderline resectable pancreatic cancer.	Up to 30 weeks.	Toxicities will be assessed according to Common Terminology Criteria for Adverse Events (CTCAE) 4.0.

Secondary Outcome Measures

Name	Time	Method
The resection rate of NAC-GEMABR therapy as neoadjuvant chemothterapy for borderline resectable pancreatic cancer.	Up to 24 weeks
The R0 resection rate of NAC-GEMABR therapy as neoadjuvant chemotherapy for borderline resectable pancreatic cancer.	Up to 30 weeks

Trial Locations

Locations (1)

Wakayama Medical University; 🇯🇵 Wakayama, Japan