Treatment of Pancreatic Cancer With Abraxane

Celgene317 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

317

Conditions

Metastatic Pancreatic Cancer

Interventions

AbraxaneDRUG

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

GemcitabineDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 \-

Locations (19)

BHB Eisenstadt

Eisenstadt, Austria

LKH Feldkirch

Feldkirch, Austria

Medical University Graz

Graz, Austria

Outcomes

Primary Outcomes

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.

Time frame: Up to 5 years

Secondary Outcomes

Best Overall Response

Tumor response will be summarized as the percentage of participants who achieve a confirmed complete (CR) or partial response (PR).

Time frame: Up to 5 years

Data from ClinicalTrials.gov

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