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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.
This observational program is aimed at gaining tolerability, safety and efficacy data with the routine use of Abraxane in its labeled indication in metastatic pancreatic cancer. Additionally data on real life dosing in daily clinical routine will be analyzed.
A detailed record of the medical history including co-morbidities and pre-treatment regimens will allow analysis of the impact thereof on tolerability, dosage and efficacy.
Hands-on experience with nab-paclitaxel is very limited in Austria and an non-interventional study could enhance knowledge on optimal drug handling and Adverse Event management.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Abraxane + Gemcitabine | Abraxane 125mg by intravenous( IV) infusion + Gemcitabine 1000mg by intravenous on Days 1, 8, 15 of every 21 day cycle until progression |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Abraxane | Drug | Abraxane By IV infusion on Days 1, 8, 15 and 28 until progression or toxicity |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Best Overall Response | Tumor response will be summarized as the percentage of participants who achieve a confirmed complete (CR) or partial response (PR). | Up to 5 years |
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Inclusion Criteria:
Exclusion Criteria:
1. 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
-
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Metastatic pancreatic cancer
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| Name | Affiliation | Role |
|---|---|---|
| Guenter Voraberger, MD | Celgene Austria | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BHB Eisenstadt | Eisenstadt | 7001 | Austria | |||
| LKH Feldkirch |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28795609 | Background | 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. | |
| 30209750 |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068196 | Albumin-Bound Paclitaxel |
| C520255 | 130-nm albumin-bound paclitaxel |
| D000093542 | Gemcitabine |
| ID | Term |
|---|---|
| D017239 | Paclitaxel |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 |
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| Gemcitabine | Drug | Gemcitabine 1000mg IV infusion on Days 1, 8, 15 and 28 until disease progression or toxicity |
|
|
| Feldkirch |
| 6800: |
| Austria |
| Medical University Graz | Graz | 8010 | Austria |
| Medical University Innsbruck | Innsbruck | 6020: | Austria |
| KH Elisabethinen Klagenfurt | Klagenfurt | 9020 | Austria |
| LKH Klagenfurt | Klagenfurt | 9020 | Austria |
| KH Krems | Krems | 3500 | Austria |
| LKH Leoben | Leoben | 8700: | Austria |
| KH Barmherzige Schwestern Linz | Linz | 4020: | Austria |
| LKH Salzburg | Salzburg | 5020: | Austria |
| LKH St. Pölten | Sankt Pölten | 3100: | Austria |
| LKH Steyr | Steyr | 4400: | Austria |
| Medical University Vienna | Vienna | 1090: | Austria |
| KH St. Josephs | Vienna | 1130 | Austria |
| KH Hanusch | Vienna | 1140 | Austria |
| LKH Vöcklabruck | Vöcklabruck | 4840: | Austria |
| Klinikum Wels | Wels | 4600: | Austria |
| LKH Wr. Neustadt | Wiener Neustadt | 2700: | Austria |
| KH Zams | Zams | 6511 | Austria |
| 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. |
| 29946913 | 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. |
| 29932294 | 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. |
| 30497432 | 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. |
| 30006989 | 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. |
| 29177608 | 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. |
| 30863113 | 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. |
| 30768369 | 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. |
| 33296830 | Derived | 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. |
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D000418 | Albumins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |