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The Effect of Gemcitabine Plus Nab-paclitaxel as Secondary Chemotherapy in Advanced Pancreatic Cancer

Primary Purpose

Pancreatic Adenocarcinoma, Chemotherapy Effect

Status
Unknown status
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Chemotherapy (Gemcitabine + nab-paclitaxel)
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Adenocarcinoma focused on measuring pancreatic cancer, second line chemotherapy, nab-paclitaxel

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers
  1. Inclusion criteria

    1. Patient whose age is 20 years or older
    2. ECOG Performance Status 0-2
    3. Pathologically confirmed pancreatic adenocarcinoma
    4. Patients with locally advanced or distant metastasis status
    5. Patients who had undergone primary chemotherapy with previous FOLFIRINOX and whose disease progress was confirmed
    6. Patients whose consent was obtained (non-insurance agreement)
  2. Exclusion Criteria

    1. Those who can not obtain consent
    2. Those who refuse chemotherapy
    3. ECOG Performance Status 3 or higher
    4. Multiple organ failure is accompanied
    5. Severe comorbidities other than cancer that do not expect a sufficient survival period over 1 month
    6. Allergy to the test drug

Sites / Locations

  • Seoul National University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Gemcitabine + nab-paclitaxel

Arm Description

Case with chemotherapy (Gemcitabine + nab-paclitaxel)

Outcomes

Primary Outcome Measures

survival rate
survival rate at 6 months after 2nd line chemotherapy

Secondary Outcome Measures

overall survival
overall survival after 2nd line chemotherapy
Progression free survival
duration till progression after 2nd line chemotherapy
Disease control rate
SD (stable disease) + PR (partial response) + CR (complete response) after 2nd line chemotherapy
adverse event
all reported adverse events after 2nd line chemotherapy

Full Information

First Posted
December 30, 2017
Last Updated
February 8, 2018
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03401827
Brief Title
The Effect of Gemcitabine Plus Nab-paclitaxel as Secondary Chemotherapy in Advanced Pancreatic Cancer
Official Title
The Effect of Gemcitabine Plus Nab-paclitaxel as Secondary Chemotherapy in Advanced Pancreatic Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2018 (Anticipated)
Primary Completion Date
January 1, 2019 (Anticipated)
Study Completion Date
January 1, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Pancreatic cancer is a very poor prognosis and has a high mortality rate. The clinical results have improved somewhat with the combination therapy of chemotherapy as the first-line treatment. However, effective secondary chemotherapy after these first-line treatment failures is limited. Recently, FOLFIRINOX has been used in patients with locally advanced or metastatic pancreatic cancer who have good performance in Korea. Gemcitabine + nab-paclitaxel (GnP) as a second-line treatment after FOLFIRINOX may be expected to be considerable. The aim of this study was to evaluate the efficacy of GnP as a second-line treatment after failed FOLFIRINOX treatment for locally advanced or metastatic pancreatic ductal adenocarcinoma.
Detailed Description
Pancreatic cancer is a very poor prognosis and has a high mortality rate. It is not clear that the improvement of clinical outcome due to anticancer drugs is not clear compared to other carcinomas. In particular, the 5-year survival rate of metastatic pancreatic cancer is still only about 2%, and the clinical results have improved somewhat with the combination therapy of chemotherapy as the first-line treatment. However, effective secondary chemotherapy after these first-line treatment failures is limited. Meta-analysis has reported that life expectancy is significantly increased in patients receiving second-line chemotherapy after failure of primary chemotherapy. However, it is not yet clear which cancer treatment is most effective. In the NCCN guideline (ver. 2017.2), the second trial of chemotherapy for locally advanced or metastatic pancreatic cancer is the most recommended clinical trial.Recently, FOLFIRINOX has been used in patients with locally advanced or metastatic pancreatic cancer who have good performance in Korea. The response rate of the treatment is 30%, and many patients require secondary chemotherapy. In a practice guideline published by the American Society of Clinical Oncology, Gemcitabine + nab-paclitaxel(GnP) is the only recommended combination for patients failing primary treatment with FOLFIRINOX. In light of the results of previous reports, the efficacy of GnP as a second-line treatment after FOLFIRINOX may be expected to be considerable, but there is a lack of studies reporting GnP therapy on the second line after FOLFIRINOX failure as a first-line treatment. The aim of this study was to evaluate the efficacy of GnP as a second-line treatment after failed FOLFIRINOX treatment for locally advanced or metastatic pancreatic ductal adenocarcinoma.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Adenocarcinoma, Chemotherapy Effect
Keywords
pancreatic cancer, second line chemotherapy, nab-paclitaxel

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Gemcitabine + nab-paclitaxel
Arm Type
Experimental
Arm Description
Case with chemotherapy (Gemcitabine + nab-paclitaxel)
Intervention Type
Drug
Intervention Name(s)
Chemotherapy (Gemcitabine + nab-paclitaxel)
Other Intervention Name(s)
GnP
Intervention Description
Nanoparticle albumin-bound paclitaxel (125 mg/m2) miv over 30 min, Day 1,8,15 Gemcitabine (1,000mg/m2) and N/S 150mL miv over 30 min, Day 1,8,15
Primary Outcome Measure Information:
Title
survival rate
Description
survival rate at 6 months after 2nd line chemotherapy
Time Frame
6 months
Secondary Outcome Measure Information:
Title
overall survival
Description
overall survival after 2nd line chemotherapy
Time Frame
till death or follow-up loss or end of study up to 2 years
Title
Progression free survival
Description
duration till progression after 2nd line chemotherapy
Time Frame
till death or follow-up loss or end of study up to 2 years
Title
Disease control rate
Description
SD (stable disease) + PR (partial response) + CR (complete response) after 2nd line chemotherapy
Time Frame
6 months
Title
adverse event
Description
all reported adverse events after 2nd line chemotherapy
Time Frame
till death or follow-up loss or end of study up to 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria Patient whose age is 20 years or older ECOG Performance Status 0-2 Pathologically confirmed pancreatic adenocarcinoma Patients with locally advanced or distant metastasis status Patients who had undergone primary chemotherapy with previous FOLFIRINOX and whose disease progress was confirmed Patients whose consent was obtained (non-insurance agreement) Exclusion Criteria Those who can not obtain consent Those who refuse chemotherapy ECOG Performance Status 3 or higher Multiple organ failure is accompanied Severe comorbidities other than cancer that do not expect a sufficient survival period over 1 month Allergy to the test drug
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jin Ho Choi, MD
Phone
82-2-2072-2228
Email
pseudo.jh@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Sang Hyub Lee, MD, Ph.D
Phone
82-2-2072-2228
Email
gidoctor@korea.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sang Hyub Lee, MD, Ph.D
Organizational Affiliation
Seoul National University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sang Hyub Lee, MD. PhD.
Phone
+82-2-2072-4892
Email
gidoctor@snuh.org

12. IPD Sharing Statement

Citations:
PubMed Identifier
34790261
Citation
Huh G, Lee HS, Choi JH, Lee SH, Paik WH, Ryu JK, Kim YT, Bang S, Lee ES. Gemcitabine plus Nab-paclitaxel as a second-line treatment following FOLFIRINOX failure in advanced pancreatic cancer: a multicenter, single-arm, open-label, phase 2 trial. Ther Adv Med Oncol. 2021 Nov 10;13:17588359211056179. doi: 10.1177/17588359211056179. eCollection 2021.
Results Reference
derived

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The Effect of Gemcitabine Plus Nab-paclitaxel as Secondary Chemotherapy in Advanced Pancreatic Cancer

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