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

Pancreatic Cancer Clinical Trial

Official title:

Phase I Study of Neoadjuvant Chemotherapy of Gemcitabine Plus Nab-paclitaxel for Patients With Borderline Resectable Pancreatic Cancer.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02506803
• Other study ID #: NAC-GEMABR
• Status: Recruiting
• Phase: Phase 1
• First received: July 22, 2015
• Last updated: May 11, 2016
• Start date: July 2015
• Est. completion date: June 2017

Study information

• Verified date: May 2016
• Source: Wakayama Medical University
• Contact: Hiroki Yamaue, M.D., PhD
• Phone: +81-73-441-0613
• Email: yamaue-h[@]wakayama-med.ac.jp
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 79 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• NAC-GEMABR
NAC-GEMABR regimen includes gemcitabine 1000mg/m2 plus nab-paclitaxel 125mg/m2 3 times weekly 1week rest.

Locations

Country	Name	City	State
Japan	Wakayama Medical University	Wakayama

Sponsors (1)

Lead Sponsor	Collaborator
Wakayama Medical University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with toxicity of NAC-GEMABR therapy as neoadjuvant chemotherapy for borderline resectable pancreatic cancer.	Toxicities will be assessed according to Common Terminology Criteria for Adverse Events (CTCAE) 4.0.	Up to 30 weeks.	No
Secondary	The resection rate of NAC-GEMABR therapy as neoadjuvant chemothterapy for borderline resectable pancreatic cancer.		Up to 24 weeks	No
Secondary	The R0 resection rate of NAC-GEMABR therapy as neoadjuvant chemotherapy for borderline resectable pancreatic cancer.		Up to 30 weeks	No