Treatment of Pancreatic Cancer With Abraxane

Metastatic Pancreatic Cancer Clinical Trial

Official title:

Multicenter Non-interventional Study to Investigate Safety, Tolerability and Efficacy of Nab-paclitaxel in Clinical Routine Treatment of First-line Pancreatic Cancer Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02555813
• Other study ID #: ABI-007-PANC-006
• Status: Completed
• Start date: May 8, 2015
• Est. completion date: September 7, 2020

Study information

• Verified date: October 2020
• Source: Celgene
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 317
• Est. completion date: September 7, 2020
• Est. primary completion date: September 7, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Metastatic pancreatic carcinoma

2. Age > 18 years

3. Signed Informed Consent

4. Normal hepatic, renal and Bone Marrow functions

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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Related Conditions & MeSH terms

• Metastatic Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• Abraxane
Abraxane By IV infusion on Days 1, 8, 15 and 28 until progression or toxicity
• Gemcitabine
Gemcitabine 1000mg IV infusion on Days 1, 8, 15 and 28 until disease progression or toxicity

Locations

Country	Name	City	State
Austria	BHB Eisenstadt	Eisenstadt
Austria	LKH Feldkirch	Feldkirch
Austria	Medical University Graz	Graz
Austria	Medical University Innsbruck	Innsbruck
Austria	KH Elisabethinen Klagenfurt	Klagenfurt
Austria	LKH Klagenfurt	Klagenfurt
Austria	KH Krems	Krems
Austria	LKH Leoben	Leoben
Austria	KH Barmherzige Schwestern Linz	Linz
Austria	LKH Salzburg	Salzburg
Austria	LKH St. Pölten	St. Pölten
Austria	LKH Steyr	Steyr
Austria	KH Hanusch	Vienna
Austria	KH St. Josephs	Vienna
Austria	Medical University Vienna	Vienna
Austria	LKH Vöcklabruck	Vöcklabruck
Austria	Klinikum Wels	Wels
Austria	LKH Wr. Neustadt	Wr. Neustadt
Austria	KH Zams	Zams

Sponsors (1)

Lead Sponsor	Collaborator
Celgene

Country where clinical trial is conducted

Austria, 

References & Publications (9)

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. — View Citation

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. — View Citation

Fernández A, Salgado M, García A, Buxò E, Vera R, Adeva J, Jiménez-Fonseca P, Quintero G, Llorca C, Cañabate M, López LJ, Muñoz A, Ramírez P, González P, López C, Reboredo M, Gallardo E, Sanchez-Cánovas M, Gallego J, Guillén C, Ruiz-Miravet N, Navarro-Pérez V, De la Cámara J, Alés-Díaz 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. — View Citation

Hegewisch-Becker S, Aldaoud A, Wolf T, Krammer-Steiner B, Linde H, Scheiner-Sparna R, Hamm D, Jänicke 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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