Treatment of Pancreatic Cancer With Abraxane

Sponsor

Celgene (Industry)

Overall Status

Completed

CT.gov ID

NCT02555813

Collaborator

(none)

317

Enrollment

Locations

Actual Duration (Months)

16.7

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Metastatic Pancreatic Cancer	Drug: Abraxane Drug: Gemcitabine

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 Design

Study Type:

Observational

Actual Enrollment :

317 participants

Observational Model:

Cohort

Time Perspective:

Cross-Sectional

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

Actual Study Start Date :

May 8, 2015

Actual Primary Completion Date :

Sep 7, 2020

Actual Study Completion Date :

Sep 7, 2020

Arms and Interventions

Arm	Intervention/Treatment
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 Abraxane By IV infusion on Days 1, 8, 15 and 28 until progression or toxicity Other Names: Nab-paclitaxel ABI-007 Drug: Gemcitabine Gemcitabine 1000mg IV infusion on Days 1, 8, 15 and 28 until disease progression or toxicity Other Names: Gemzar

Arm

Intervention/Treatment

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

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

Other Names:

Nab-paclitaxel

ABI-007

Drug: Gemcitabine

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

Other Names:

Gemzar

Outcome Measures

Primary Outcome Measures

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

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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	BHB Eisenstadt	Eisenstadt	Austria	7001
2	LKH Feldkirch	Feldkirch	Austria	6800:
3	Medical University Graz	Graz	Austria	8010
4	Medical University Innsbruck	Innsbruck	Austria	6020:
5	KH Elisabethinen Klagenfurt	Klagenfurt	Austria	9020
6	LKH Klagenfurt	Klagenfurt	Austria	9020
7	KH Krems	Krems	Austria	3500
8	LKH Leoben	Leoben	Austria	8700:
9	KH Barmherzige Schwestern Linz	Linz	Austria	4020:
10	LKH Salzburg	Salzburg	Austria	5020:
11	LKH St. Pölten	St. Pölten	Austria	3100:
12	LKH Steyr	Steyr	Austria	4400:
13	Medical University Vienna	Vienna	Austria	1090:
14	KH St. Josephs	Vienna	Austria	1130
15	KH Hanusch	Vienna	Austria	1140
16	LKH Vöcklabruck	Vöcklabruck	Austria	4840:
17	Klinikum Wels	Wels	Austria	4600:
18	LKH Wr. Neustadt	Wr. Neustadt	Austria	2700:
19	KH Zams	Zams	Austria	6511