Treatment of Pancreatic Cancer With Abraxane

NCT02555813 | Completed

• 1 other identifier: ABI-007-PANC-006
• Study Type: observational
• Target: 317
• Locations: 1 country
• Sites: 19

Brief Summary

This observational program collects data on tolerability, safety and efficacy regarding the use of Abraxane in metastatic pancreatic cancer patients in the daily clinical routine. Additionally data on dosage that is actually used in these patients will be collected. Patients who have pancreatic cancer and additional diseases can be documented in this study, too. Collected data might generate learnings on the optimal use of Abraxane in the daily routine setting.

Conditions

Metastatic Pancreatic Cancer

Keywords

Metastatic Pancreatic Cancer; nab-Paclitaxel; Gemcitabine; Non-interventional

Outcome Measures

Primary Outcomes (1)

• Number of participants with adverse events

  An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a subject during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the subject's health, including laboratory test values, regardless of etiology.

  Up to 5 years

Secondary Outcomes (1)

• Best Overall Response

  Up to 5 years

Study Arms (1)

Abraxane + Gemcitabine

Abraxane 125mg by intravenous( IV) infusion + Gemcitabine 1000mg by intravenous on Days 1, 8, 15 of every 21 day cycle until progression

Drug: Abraxane; Drug: Gemcitabine

Interventions

Abraxane DRUG

Abraxane By IV infusion on Days 1, 8, 15 and 28 until progression or toxicity

Also known as: Nab-paclitaxel, ABI-007

Abraxane + Gemcitabine

Gemcitabine DRUG

Gemcitabine 1000mg IV infusion on Days 1, 8, 15 and 28 until disease progression or toxicity

Also known as: Gemzar

Abraxane + Gemcitabine

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

Metastatic pancreatic cancer

You may qualify if:

• Metastatic pancreatic carcinoma
• Age \> 18 years
• Signed Informed Consent
• Normal hepatic, renal and Bone Marrow functions

You may not qualify if:

• \. Pregnant and lactating females 2. Previous treatment for metastatic pancreatic disease 3. Known hypersensitivity to nab-paclitaxel 4. Neutrophils \< 1,5 x 10\^9/L

Sponsors & Collaborators

• Celgene: lead

Study Sites (19)

BHB Eisenstadt

Eisenstadt, 7001, Austria

Location

LKH Feldkirch

Feldkirch, 6800:, Austria

Location

Medical University Graz

Graz, 8010, Austria

Location

Medical University Innsbruck

Innsbruck, 6020:, Austria

Location

KH Elisabethinen Klagenfurt

Klagenfurt, 9020, Austria

Location

LKH Klagenfurt

Klagenfurt, 9020, Austria

Location

KH Krems

Krems, 3500, Austria

Location

LKH Leoben

Leoben, 8700:, Austria

Location

KH Barmherzige Schwestern Linz

Linz, 4020:, Austria

Location

LKH Salzburg

Salzburg, 5020:, Austria

Location

LKH St. Pölten

Sankt Pölten, 3100:, Austria

Location

LKH Steyr

Steyr, 4400:, Austria

Location

Medical University Vienna

Vienna, 1090:, Austria

Location

KH St. Josephs

Vienna, 1130, Austria

Location

KH Hanusch

Vienna, 1140, Austria

Location

LKH Vöcklabruck

Vöcklabruck, 4840:, Austria

Location

Klinikum Wels

Wels, 4600:, Austria

Location

LKH Wr. Neustadt

Wiener Neustadt, 2700:, Austria

Location

KH Zams

Zams, 6511, Austria

Location

Related Publications (10)

• McBride A, Bonafede M, Cai Q, Princic N, Tran O, Pelletier C, Parisi M, Patel M. Comparison of treatment patterns and economic outcomes among metastatic pancreatic cancer patients initiated on nab-paclitaxel plus gemcitabine versus FOLFIRINOX. Expert Rev Clin Pharmacol. 2017 Oct;10(10):1153-1160. doi: 10.1080/17512433.2017.1365598. Epub 2017 Aug 21.

  PMID: 28795609 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

• 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

• 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

• Prager GW, Oehler L, Gerger A, Mlineritsch B, Andel J, Petzer A, Wilthoner K, Sliwa T, Pichler P, Winder T, Heibl S, Gruenberger B, Laengle F, Hubmann E, Korger M, Pecherstorfer M, Djanani A, Neumann HJ, Philipp-Abbrederis K, Woll E, Trondl R, Arnold-Schrauf C, Eisterer W. Comparison of nab-paclitaxel plus gemcitabine in elderly versus younger patients with metastatic pancreatic cancer: Analysis of a multicentre, prospective, non-interventional study. Eur J Cancer. 2021 Jan;143:101-112. doi: 10.1016/j.ejca.2020.11.003. Epub 2020 Dec 6.

  PMID: 33296830 DERIVED

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Albumin-Bound Paclitaxel; 130-nm albumin-bound paclitaxel; Gemcitabine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Study Officials

• Guenter Voraberger, MD

  Celgene Austria

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: September 18, 2015
• First Posted: September 22, 2015
• Study Start: May 8, 2015
• Primary Completion: September 7, 2020
• Study Completion: September 7, 2020
• Last Updated: October 19, 2020

Record last verified: 2020-10

Locations

AU (19)