A Study to Assess Clinical an Patient Reported Outcomes With Nab-paclitaxel in Combination With Gemcitabine in Route Clinical Practice Treating Pancreatic Cancer

NCT02670746 | Terminated

• 1 other identifier: ABI-007-PANC-008
• Study Type: observational
• Target: 44
• Locations: 1 country
• Sites: 18

Brief Summary

The objective of the study is to prospectively assess the use and treatment outcomes of nab-paclitaxel plus gemcitabine in pancreatic ductal adenocarcinoma in the Netherlands. Additional objectives are to monitor the incidence and reversibility of neuropathy during treatment, to assess the patient's Quality of life when treated with nab-paclitaxel/gemcitabine and to evaluate the use of resources that come with treating metastatic pancreatic cancer.

Conditions

Pancreatic Neoplasms

Keywords

Pancreatic Cancer; Observational; Nab-Paclitaxel; Abraxane; ABI-007; Gemcitabine; Non-interventional; Netherlands; Quality of Life

Outcome Measures

Primary Outcomes (2)

• Overall survival

  Survival is defined as the time from the first dose of nab-paclitaxel in combination with gemcitabine date to the date of death (any cause).

  Up to approximately 3 years

• Adverse Event (AE)

  Adverse events will be classified using the MedDRA classification system. The severity of the toxicities will be graded according to the NCI CTCAE VERSION 4.03 whenever possible.

  Up to approximately 3 years

Secondary Outcomes (6)

• Change from baseline in the EORTC-QLQ-CIPN-20 (European Organization for Research and Treatment of Cancer Quality of Life Instrument In Patients With Chemotherapy Induced Peripheral Neuropathy )

  up to approximately 3 years

• Change from baseline in the EORTC-QLQ-C30 (European Organization for Research and Treatment of Cancer Quality of Life Instrument)

  up to approximately 3 years

• Change from baseline in the EuroQuality of Life : EQ5D-3L

  up to approximately 3 years

• Evaluate the incidence of neuropathy - grade 1-5

  up to approximately 3 years

• Evaluate reversibility of neuropathy to Gr ≤1

  up to approximately 3 years

Study Arms (1)

Nab-paclitaxel in combination with gemcitabine (AG)

The objective is to prospectively assess the use and treatment outcomes of nab-paclitaxel plus gemcitabine in pancreatic ductal adenocarcinoma. In all cases, the decision to treat the patient with nab-paclitaxel in combination with gemcitabine was already made prior to the decision to enter the subject into the study. Treatment will be according to routine clinical practice and based on recommendations as per Summary of Product Characteristics (SPC).

Eligibility Criteria

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

Study Population

Two-hundred adult patients treated with the combination nab-paclitaxel and gemcitabine (AG) for metastatic pancreatic adenocarcinoma will be recruited from approximately 25 oncology sites in the Netherlands. In all cases, the decision to treat the patient with AG was already made prior to the decision to enter the subject into the study. Treatment will be according to routine clinical practice and based on recommendations as per SmPC.

You may qualify if:

• Patients over 18 years of age who understand and voluntarily sign an informed consent form.
• Patients treated for pancreatic adenocarcinoma.

You may not qualify if:

• Patients currently treated for metastatic pancreatic cancer with other therapy than nab-paclitaxel plus gemcitabine
• Refusal to participate in the study.
• Women who are pregnant or breast-feeding.
• Hypersensitivity to the active substance or to any of the excipients.
• Participation in interventional trials during the period of treatment with nab-paclitaxel

Sponsors & Collaborators

• Celgene: lead

Study Sites (18)

Rijnstate Ziekenhuis

Arnhem, Gelderland, 6815 A, Netherlands

Location

Amphia ziekenhuis

Breda, Gelderland, 4818 CK, Netherlands

Location

Gelderse Vallei

Ede, North Brabant, 2545 CH, Netherlands

Location

Elkerliek Ziekenhuis

Helmond, North Brabant, 5707 HA, Netherlands

Location

Maxima Medisch Centrum

Veldhoven, North Brabant, 5504 DB, Netherlands

Location

BovenIJ Ziekenhuis

Amsterdam, North Holland, 1034 CS, Netherlands

Location

Academic Medical Centre

Amsterdam, North Holland, 1105 AZ, Netherlands

Location

Spaarne Gasthuis

Haarlem, North Holland, 2035 RC, Netherlands

Location

Tergooi

Hilversum, North Holland, 1213XZ, Netherlands

Location

Isala

Zwolle, Overijssel, 8025 AB, Netherlands

Location

Ziekenhuis de Tjongerschans

Heerenveen, Provincie Friesland, 8841 PW, Netherlands

Location

Antonius Ziekenhuis Sneek

Sneek, Provincie Friesland, 8601 ZK, Netherlands

Location

Albert Schweitzer Ziekenhuis

Dordrecht, South Holland, 3328 AT, Netherlands

Location

LUMC

Leiden, South Holland, 2333 ZA, Netherlands

Location

HagaZiekenhuis

The Hague, South Holland, 2545 CH, Netherlands

Location

Zorgsaam Zeeuws -Vlaanderen

Terneuzen, Zeeland, 4535 PA, Netherlands

Location

Martini Ziekenhuis

Groningen, 9728 NT, Netherlands

Location

UMC Utrecht

Utrecht, 3584 CX, Netherlands

Location

Related Publications (13)

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  PMID: 30149366 BACKGROUND

• Vogl DT, Raje N, Jagannath S, Richardson P, Hari P, Orlowski R, Supko JG, Tamang D, Yang M, Jones SS, Wheeler C, Markelewicz RJ, Lonial S. Ricolinostat, the First Selective Histone Deacetylase 6 Inhibitor, in Combination with Bortezomib and Dexamethasone for Relapsed or Refractory Multiple Myeloma. Clin Cancer Res. 2017 Jul 1;23(13):3307-3315. doi: 10.1158/1078-0432.CCR-16-2526. Epub 2017 Jan 4.

  PMID: 28053023 BACKGROUND

• Kim S, Signorovitch JE, Yang H, Patterson-Lomba O, Xiang CQ, Ung B, Parisi M, Marshall JL. Comparative Effectiveness of nab-Paclitaxel Plus Gemcitabine vs FOLFIRINOX in Metastatic Pancreatic Cancer: A Retrospective Nationwide Chart Review in the United States. Adv Ther. 2018 Oct;35(10):1564-1577. doi: 10.1007/s12325-018-0784-z. Epub 2018 Sep 12.

  PMID: 30209750 BACKGROUND

• Cartwright TH, Parisi M, Espirito JL, Wilson TW, Pelletier C, Patel M, Babiker HM. Clinical Outcomes with First-Line Chemotherapy in a Large Retrospective Study of Patients with Metastatic Pancreatic Cancer Treated in a US Community Oncology Setting. Drugs Real World Outcomes. 2018 Sep;5(3):149-159. doi: 10.1007/s40801-018-0137-x.

  PMID: 29946913 BACKGROUND

• Pelzer U, Wislocka L, Juhling A, Striefler J, Klein F, Roemmler-Zehrer J, Sinn M, Denecke T, Bahra M, Riess H. Safety and efficacy of Nab-paclitaxel plus gemcitabine in patients with advanced pancreatic cancer suffering from cholestatic hyperbilirubinaemia-A retrospective analysis. Eur J Cancer. 2018 Sep;100:85-93. doi: 10.1016/j.ejca.2018.06.001. Epub 2018 Jul 4.

  PMID: 30014884 BACKGROUND

• Young R, Mainwaring P, Clingan P, Parnis FX, Asghari G, Beale P, Aly A, Botteman M, Romano A, Ferrara S, Margunato-Debay S, Harris M. nab-Paclitaxel plus gemcitabine in metastatic pancreatic adenocarcinoma: Australian subset analyses of the phase III MPACT trial. Asia Pac J Clin Oncol. 2018 Oct;14(5):e325-e331. doi: 10.1111/ajco.12999. Epub 2018 Jun 22.

  PMID: 29932294 BACKGROUND

• Neumann CCM, von Horschelmann E, Reutzel-Selke A, Seidel E, Sauer IM, Pratschke J, Bahra M, Schmuck RB. Tumor-stromal cross-talk modulating the therapeutic response in pancreatic cancer. Hepatobiliary Pancreat Dis Int. 2018 Oct;17(5):461-472. doi: 10.1016/j.hbpd.2018.09.004. Epub 2018 Sep 7.

  PMID: 30243879 BACKGROUND

• Veenstra VL, Damhofer H, Waasdorp C, van Rijssen LB, van de Vijver MJ, Dijk F, Wilmink HW, Besselink MG, Busch OR, Chang DK, Bailey PJ, Biankin AV, Kocher HM, Medema JP, Li JS, Jiang R, Pierce DW, van Laarhoven HWM, Bijlsma MF. ADAM12 is a circulating marker for stromal activation in pancreatic cancer and predicts response to chemotherapy. Oncogenesis. 2018 Nov 16;7(11):87. doi: 10.1038/s41389-018-0096-9.

  PMID: 30442938 BACKGROUND

• Fernandez A, Salgado M, Garcia A, Buxo E, Vera R, Adeva J, Jimenez-Fonseca P, Quintero G, Llorca C, Canabate M, Lopez LJ, Munoz A, Ramirez P, Gonzalez P, Lopez C, Reboredo M, Gallardo E, Sanchez-Canovas M, Gallego J, Guillen C, Ruiz-Miravet N, Navarro-Perez V, De la Camara J, Ales-Diaz I, Pazo-Cid RA, Carmona-Bayonas A. Prognostic factors for survival with nab-paclitaxel plus gemcitabine in metastatic pancreatic cancer in real-life practice: the ANICE-PaC study. BMC Cancer. 2018 Nov 29;18(1):1185. doi: 10.1186/s12885-018-5101-3.

  PMID: 30497432 BACKGROUND

• Hegewisch-Becker S, Aldaoud A, Wolf T, Krammer-Steiner B, Linde H, Scheiner-Sparna R, Hamm D, Janicke M, Marschner N; TPK-Group (Tumour Registry Pancreatic Cancer). Results from the prospective German TPK clinical cohort study: Treatment algorithms and survival of 1,174 patients with locally advanced, inoperable, or metastatic pancreatic ductal adenocarcinoma. Int J Cancer. 2019 Mar 1;144(5):981-990. doi: 10.1002/ijc.31751. Epub 2018 Oct 3.

  PMID: 30006989 BACKGROUND

• Barnes JA, Ellis ML, Hwang S, Emarine J, Merwin P, Salinas GD, Musher BL. Identification of Educational Gaps Among Oncologists Who Manage Patients with Pancreatic Cancer. J Gastrointest Cancer. 2019 Mar;50(1):84-90. doi: 10.1007/s12029-017-0033-8.

  PMID: 29177608 BACKGROUND

• Woo W, Carey ET, Choi M. Spotlight on liposomal irinotecan for metastatic pancreatic cancer: patient selection and perspectives. Onco Targets Ther. 2019 Feb 21;12:1455-1463. doi: 10.2147/OTT.S167590. eCollection 2019.

  PMID: 30863113 BACKGROUND

• Sonbol MB, Ahn DH, Goldstein D, Okusaka T, Tabernero J, Macarulla T, Reni M, Li CP, O'Neil B, Van Cutsem E, Bekaii-Saab T. CanStem111P trial: a Phase III study of napabucasin plus nab-paclitaxel with gemcitabine. Future Oncol. 2019 Apr;15(12):1295-1302. doi: 10.2217/fon-2018-0903. Epub 2019 Feb 15.

  PMID: 30768369 BACKGROUND

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Jeroen Stevens, Msc

  Celgene Corporation

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2015
• First Posted: February 2, 2016
• Study Start: October 1, 2015
• Primary Completion: November 28, 2017
• Study Completion: November 28, 2017
• Last Updated: September 16, 2019

Record last verified: 2019-09

Locations

NL (18)