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

Primary Purpose

Pancreatic Cancer

Status

Unknown status

Phase

Phase 1

Locations

Japan

Study Type

Interventional

Intervention

NAC-GEMABR

About this trial

This is an interventional treatment trial for Pancreatic Cancer

Eligibility Criteria

20 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Wakayama Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

NAC-GEMABR

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

The resection rate of NAC-GEMABR therapy as neoadjuvant chemothterapy for borderline resectable pancreatic cancer.

The R0 resection rate of NAC-GEMABR therapy as neoadjuvant chemotherapy for borderline resectable pancreatic cancer.

Full Information

NCT ID

NCT02506803

First Posted

July 22, 2015

Last Updated

May 11, 2016

Sponsor

Wakayama Medical University

1. Study Identification

Unique Protocol Identification Number

NCT02506803

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2016

Overall Recruitment Status

Unknown status

Study Start Date

July 2015 (undefined)

Primary Completion Date

June 2017 (Anticipated)

Study Completion Date

June 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Wakayama Medical University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pancreatic Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

NAC-GEMABR

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

NAC-GEMABR

Other Intervention Name(s)

Gemcitabine, nab-paclitaxel

Intervention Description

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

Primary Outcome Measure Information:

Title

Number of participants with toxicity of NAC-GEMABR therapy as neoadjuvant chemotherapy for borderline resectable pancreatic cancer.

Description

Toxicities will be assessed according to Common Terminology Criteria for Adverse Events (CTCAE) 4.0.

Time Frame

Up to 30 weeks.

Secondary Outcome Measure Information:

Title

The resection rate of NAC-GEMABR therapy as neoadjuvant chemothterapy for borderline resectable pancreatic cancer.

Time Frame

Up to 24 weeks

Title

The R0 resection rate of NAC-GEMABR therapy as neoadjuvant chemotherapy for borderline resectable pancreatic cancer.

Time Frame

Up to 30 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

79 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Pathologically proven invasive pancreatic ductal carcinoma Cases that meet the definition of borderline resectable pancreatic cancer 1) or 2) Definition of a borderline resectable pancreatic cancer is filledin NCCN guideline version 1.2014 pancreatic adenocarcinoma 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Hiroki Yamaue, M.D., PhD

Phone

+81-73-441-0613

Ext

5112

yamaue-h@wakayama-med.ac.jp

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hiroki Yamaue, M.D., PhD

Organizational Affiliation

Wakayama Medical University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Wakayama Medical University

City

Wakayama

ZIP/Postal Code

641-8510

Country

Japan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Hiroki Yamaue, M.D., PhD

First Name & Middle Initial & Last Name & Degree

Ken-ichi Okada, M.D., PhD

First Name & Middle Initial & Last Name & Degree

Manabu Kawai, M.D., PhD

First Name & Middle Initial & Last Name & Degree

Seiko Hirono, M.D., PhD

First Name & Middle Initial & Last Name & Degree

Motoki Miyazawa, M.D., PhD

First Name & Middle Initial & Last Name & Degree

Atsushi Shimizu, M.D., PhD

First Name & Middle Initial & Last Name & Degree

Yuji Kitahata, M.D., PhD

12. IPD Sharing Statement

Citations:

PubMed Identifier

28179342

Citation

Okada KI, Hirono S, Kawai M, Miyazawa M, Shimizu A, Kitahata Y, Ueno M, Hayami S, Yamaue H. Phase I Study of Nab-Paclitaxel plus Gemcitabine as Neoadjuvant Therapy for Borderline Resectable Pancreatic Cancer. Anticancer Res. 2017 Feb;37(2):853-858. doi: 10.21873/anticanres.11389.

Results Reference

derived

Learn more about this trial

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

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