Treatment of Pancreatic Cancer With Abraxane

Completed

• Conditions: Metastatic Pancreatic Cancer
• Interventions: Drug: Abraxane; Drug: Gemcitabine

• Registration Number: NCT02555813
• Lead Sponsor: Celgene

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.

Detailed 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.

Study Timeline

• Study Start: 2015-05-08
• Study First Submitted: 2015-09-18
• Study First Submitted QC: 2015-09-18
• Study First Posted: 2015-09-22
• Primary Completion: 2020-09-07
• Study Completion: 2020-09-07
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-15
• Last Update Posted: 2020-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 317

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Number of participants with adverse events	Up to 5 years	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.

Secondary Outcome Measures

Name	Time	Method
Best Overall Response	Up to 5 years	Tumor response will be summarized as the percentage of participants who achieve a confirmed complete (CR) or partial response (PR).

Trial Locations

Locations (19)

LKH Feldkirch; 🇦🇹 Feldkirch, Austria

KH Krems; 🇦🇹 Krems, Austria

LKH Leoben; 🇦🇹 Leoben, Austria

LKH Salzburg; 🇦🇹 Salzburg, Austria

LKH St. Pölten; 🇦🇹 St. Pölten, Austria

KH Hanusch; 🇦🇹 Vienna, Austria

Klinikum Wels; 🇦🇹 Wels, Austria

KH Barmherzige Schwestern Linz; 🇦🇹 Linz, Austria

Medical University Innsbruck; 🇦🇹 Innsbruck, Austria

KH Elisabethinen Klagenfurt; 🇦🇹 Klagenfurt, Austria

Medical University Vienna; 🇦🇹 Vienna, Austria

LKH Klagenfurt; 🇦🇹 Klagenfurt, Austria

LKH Wr. Neustadt; 🇦🇹 Wr. Neustadt, Austria

KH Zams; 🇦🇹 Zams, Austria

BHB Eisenstadt; 🇦🇹 Eisenstadt, Austria

KH St. Josephs; 🇦🇹 Vienna, Austria

LKH Vöcklabruck; 🇦🇹 Vöcklabruck, Austria

Medical University Graz; 🇦🇹 Graz, Austria

LKH Steyr; 🇦🇹 Steyr, Austria