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

NCT04133155 | Completed FDA Drug

• 1 other identifier: AX-NI-PANC-PI-13883
• Study Type: observational
• Target: 103
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pancreatic Cancer; Metastatic Pancreatic Cancer

Keywords

Pancreatic cancer; FOLFIRINOX; nab-paclitaxel plus gemcitabine

Outcome Measures

Primary Outcomes (1)

• Progression-free survival

  Time from the start of 2nd-line nab-P + GEM to disease progression or death from any cause, whichever came first

  1 year

Secondary Outcomes (3)

• Overall survival

  1 year

• Objective response rates

  1 year

• Toxicity profile

  1 year

Study Arms (1)

nab-P + GEM

Nab-paclitaxel plus gemcitabine

Drug: nab paclitaxel plus gemcitabine

Interventions

nab paclitaxel plus gemcitabine DRUG

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

Also known as: Abraxane

nab-P + GEM

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Pathologically confirmed pancreatic ductal adenocarcinoma who received 2nd-line nab-paclitaxel plus gemcitabine after progression on 1st-line FOLFIRINOX

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Asan Medical Center: lead
• Bundang CHA Hospital: collaborator
• Ulsan University Hospital: collaborator

Study Sites (1)

Asan Medical Center

Seoul, 05505, South Korea

Location

Related Publications (5)

• 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.

  PMID: 26487945 BACKGROUND

• 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.

  PMID: 30536151 BACKGROUND

• 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.

  PMID: 24559766 BACKGROUND

• 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.

  PMID: 28599496 BACKGROUND

• 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.

  PMID: 32523632 DERIVED

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Taxes; Gemcitabine; Albumin-Bound Paclitaxel

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Economics; Health Care Economics and Organizations; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Changhoon Yoo, MD

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: October 17, 2019
• First Posted: October 21, 2019
• Study Start: September 16, 2019
• Primary Completion: January 1, 2020
• Study Completion: February 1, 2020
• Last Updated: March 13, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)