Clinical trial NCT02506803: 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
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Pancreatic Cancer
Lead sponsor: Wakayama Medical University
Sponsor class: OTHER
First posted: 2015-07-23
Enrollment: 10
Sex: ALL
Minimum age (years): 20
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of participants with toxicity of NAC-GEMABR therapy as neoadjuvant chemotherapy for borderline resectable pancreatic cancer.
timeFrame: Up to 30 weeks.
Secondary outcomes:
measure: The resection rate of NAC-GEMABR therapy as neoadjuvant chemothterapy for borderline resectable pancreatic cancer.
timeFrame: Up to 24 weeks
measure: The R0 resection rate of NAC-GEMABR therapy as neoadjuvant chemotherapy for borderline resectable pancreatic cancer.
timeFrame: Up to 30 weeks
Other outcomes:
Locations:
city: Wakayama
country: Japan
facility: Wakayama Medical University
Study officials:
affiliation: Wakayama Medical University
name: Hiroki Yamaue, M.D., PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.