Retrospective Analysis of 2nd-line Nab-Paclitaxel + Gemcitabine After 1st-line FOLFIRINOX in Pancreatic Cancer

NCT ID: NCT04133155

Last Updated: 2020-03-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

103 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-09-16

Study Completion Date

2020-02-01

Brief Summary

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In this study, clinical data of patients who received 2nd-line Nab-paclitaxel plus Gemcitabine (nab-P+GEM) after progression on 1st-line FOLFIRINOX will be reviewed retrospectively.

Detailed Description

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FOLFIRINOX is one of standard 1 st-line regimens for patients with advanced PDAC. However, there is no globally established 2 nd-line regimen after the failure of FOLFIRINOX. Although gemcitabine-based regimens are recommended by multiple guidelines and widely used in daily practice, further analysis is needed to reveal the magnitude of clinical benefit with these regimens. Nab-paclitaxel plus Gemcitabine (Nab-P+Gem) is another standard 1 st-line regimen for PDAC, but there are limited data as 2 nd-line therapy in PDAC. Therefore, the investigators are conducting a multicenter retrospective analysis of 2 nd-line nab-P+Gem after progression on FOLFIRINOX in patients with advanced PDAC.

Conditions

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Pancreatic Cancer Metastatic Pancreatic Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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nab-P + GEM

Nab-paclitaxel plus gemcitabine

nab paclitaxel plus gemcitabine

Intervention Type DRUG

Nab-paclitaxel 125 mg/m2 weekly for 3 weeks, every 4 weeks Gemcitabine 1000 mg/m2 weekly for 3 weeks, every 4 weeks

Interventions

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nab paclitaxel plus gemcitabine

Nab-paclitaxel 125 mg/m2 weekly for 3 weeks, every 4 weeks Gemcitabine 1000 mg/m2 weekly for 3 weeks, every 4 weeks

Intervention Type DRUG

Other Intervention Names

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Abraxane

Eligibility Criteria

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Inclusion Criteria

* Pathologically confirmed pancreatic ductal adenocarcinoma
* Administration of 2nd-line nab-paclitaxel plus gemcitabine
* Progression on 1st-line FOLFIRINOX

Exclusion Criteria

* Pathologic diagnosis other than pancreatic ductal adenocarcinoma
* Administration of nab-paclitaxel plus gemcitabine as 3rd or greater lines of therapy
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bundang CHA Hospital

OTHER

Sponsor Role collaborator

Ulsan University Hospital

OTHER

Sponsor Role collaborator

Asan Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Changhoon Yoo

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Changhoon Yoo, MD

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

Locations

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Asan Medical Center

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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Portal A, Pernot S, Siauve N, Landi B, Lepere C, Colussi O, Rougier P, Zaanan A, Verriere B, Taieb J. Sustained response with gemcitabine plus Nab-paclitaxel after folfirinox failure in metastatic pancreatic cancer: report of an effective new strategy. Clin Res Hepatol Gastroenterol. 2014 Apr;38(2):e23-6. doi: 10.1016/j.clinre.2014.01.005. Epub 2014 Feb 18.

Reference Type BACKGROUND
PMID: 24559766 (View on PubMed)

Sarabi M, Mais L, Oussaid N, Desseigne F, Guibert P, De La Fouchardiere C. Use of gemcitabine as a second-line treatment following chemotherapy with folfirinox for metastatic pancreatic adenocarcinoma. Oncol Lett. 2017 Jun;13(6):4917-4924. doi: 10.3892/ol.2017.6061. Epub 2017 Apr 20.

Reference Type BACKGROUND
PMID: 28599496 (View on PubMed)

Chae H, Jeong H, Cheon J, Chon HJ, Ryu H, Kim IH, Kang MJ, Jeong JH, Ryoo BY, Kim KP, Yoo C. Efficacy and safety of second-line nab-paclitaxel plus gemcitabine after progression on FOLFIRINOX for unresectable or metastatic pancreatic ductal adenocarcinoma: multicenter retrospective analysis. Ther Adv Med Oncol. 2020 May 27;12:1758835920923424. doi: 10.1177/1758835920923424. eCollection 2020.

Reference Type DERIVED
PMID: 32523632 (View on PubMed)

da Rocha Lino A, Abrahao CM, Brandao RM, Gomes JR, Ferrian AM, Machado MC, Buzaid AC, Maluf FC, Peixoto RD. Role of gemcitabine as second-line therapy after progression on FOLFIRINOX in advanced pancreatic cancer: a retrospective analysis. J Gastrointest Oncol. 2015 Oct;6(5):511-5. doi: 10.3978/j.issn.2078-6891.2015.041.

Reference Type BACKGROUND
PMID: 26487945 (View on PubMed)

Kang J, Yoo C, Hwang HS, Hong SM, Kim KP, Kim SY, Hong YS, Kim TW, Ryoo BY. Efficacy and safety of lanreotide in Korean patients with metastatic, well-differentiated gastroenteropancreatic-neuroendocrine tumors: a retrospective analysis. Invest New Drugs. 2019 Aug;37(4):763-770. doi: 10.1007/s10637-018-0710-x. Epub 2018 Dec 10.

Reference Type BACKGROUND
PMID: 30536151 (View on PubMed)

Other Identifiers

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AX-NI-PANC-PI-13883

Identifier Type: -

Identifier Source: org_study_id

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