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

February 8, 2018 updated by: Sang Hyub Lee, Seoul National University Hospital
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 110-744
        • Recruiting
        • Seoul National University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

  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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Gemcitabine + nab-paclitaxel
Case with chemotherapy (Gemcitabine + nab-paclitaxel)
Drug: Chemotherapy (Gemcitabine + nab-paclitaxel)

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

Other Names:
  • GnP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
survival rate
Time Frame: 6 months
survival rate at 6 months after 2nd line chemotherapy
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
overall survival
Time Frame: till death or follow-up loss or end of study up to 2 years
overall survival after 2nd line chemotherapy
till death or follow-up loss or end of study up to 2 years
Progression free survival
Time Frame: till death or follow-up loss or end of study up to 2 years
duration till progression after 2nd line chemotherapy
till death or follow-up loss or end of study up to 2 years
Disease control rate
Time Frame: 6 months
SD (stable disease) + PR (partial response) + CR (complete response) after 2nd line chemotherapy
6 months
adverse event
Time Frame: till death or follow-up loss or end of study up to 2 years
all reported adverse events after 2nd line chemotherapy
till death or follow-up loss or end of study up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Investigators

  • Study Director: Sang Hyub Lee, MD, Ph.D, Seoul National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 1, 2018

Primary Completion (Anticipated)

January 1, 2019

Study Completion (Anticipated)

January 1, 2019

Study Registration Dates

First Submitted

December 30, 2017

First Submitted That Met QC Criteria

January 16, 2018

First Posted (Actual)

January 17, 2018

Study Record Updates

Last Update Posted (Actual)

February 12, 2018

Last Update Submitted That Met QC Criteria

February 8, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-1710-067-894

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pancreatic Adenocarcinoma

Clinical Trials on Chemotherapy (Gemcitabine + nab-paclitaxel)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Poland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe