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

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ClinicalTrials.gov Identifier: NCT03401827
Recruitment Status : Unknown
Verified January 2018 by Sang Hyub Lee, Seoul National University Hospital.
Recruitment status was:  Recruiting
First Posted : January 17, 2018
Last Update Posted : February 12, 2018
Sponsor:
Information provided by (Responsible Party):
Sang Hyub Lee, Seoul National University Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Pancreatic Adenocarcinoma Chemotherapy Effect Drug: Chemotherapy (Gemcitabine + nab-paclitaxel) Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Gemcitabine Plus Nab-paclitaxel as Secondary Chemotherapy in Advanced Pancreatic Cancer
Estimated Study Start Date : March 1, 2018
Estimated Primary Completion Date : January 1, 2019
Estimated Study Completion Date : January 1, 2019

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Arms and Interventions
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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 Name: GnP


Outcome Measures
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Primary Outcome Measures :
  1. survival rate [ Time Frame: 6 months ]
    survival rate at 6 months after 2nd line chemotherapy


Secondary Outcome Measures :
  1. overall survival [ Time Frame: till death or follow-up loss or end of study up to 2 years ]
    overall survival after 2nd line chemotherapy

  2. 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

  3. Disease control rate [ Time Frame: 6 months ]
    SD (stable disease) + PR (partial response) + CR (complete response) after 2nd line chemotherapy

  4. 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


Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

  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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03401827


Contacts
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Contact: Jin Ho Choi, MD 82-2-2072-2228 pseudo.jh@gmail.com
Contact: Sang Hyub Lee, MD, Ph.D 82-2-2072-2228 gidoctor@korea.com

Locations
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Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 110-744
Contact: Sang Hyub Lee, MD. PhD.    +82-2-2072-4892    gidoctor@snuh.org   
Sponsors and Collaborators
Seoul National University Hospital
Investigators
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Study Director: Sang Hyub Lee, MD, Ph.D Seoul National University Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Sang Hyub Lee, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT03401827    
Other Study ID Numbers: H-1710-067-894
First Posted: January 17, 2018    Key Record Dates
Last Update Posted: February 12, 2018
Last Verified: January 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sang Hyub Lee, Seoul National University Hospital:
pancreatic cancer
second line chemotherapy
nab-paclitaxel
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Paclitaxel
 Gemcitabine
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites