NCT02506803

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for phase_1 pancreatic-cancer

Timeline
Completed

Started Jul 2015

Shorter than P25 for phase_1 pancreatic-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

July 22, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 23, 2015

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

May 12, 2016

Status Verified

May 1, 2016

Enrollment Period

1.9 years

First QC Date

July 22, 2015

Last Update Submit

May 11, 2016

Conditions

Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

  • 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.

Secondary Outcomes (2)

  • 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

Study Arms (1)

NAC-GEMABR

EXPERIMENTAL

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

Drug: NAC-GEMABR

Interventions

NAC-GEMABRDRUG

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

Also known as: Gemcitabine, nab-paclitaxel
NAC-GEMABR

Eligibility Criteria

Age20 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wakayama Medical University

Wakayama, 641-8510, Japan

RECRUITING

Related Publications (1)

  • 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.

    PMID: 28179342DERIVED

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Gemcitabine130-nm albumin-bound paclitaxel

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Hiroki Yamaue, M.D., PhD

    Wakayama Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hiroki Yamaue, M.D., PhD

CONTACT

+81-73-441-0613yamaue-h@wakayama-med.ac.jp

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dean & Professor of the second department of surgery

Study Record Dates

First Submitted

July 22, 2015

First Posted

July 23, 2015

Study Start

July 1, 2015

Primary Completion

June 1, 2017

Study Completion

June 1, 2017

Last Updated

May 12, 2016

Record last verified: 2016-05

Locations

JP(1)