Nab-Paclitaxel Plus Gemcitabine Versus Gemcitabine For The First Line Treatment Of Pancreas Cancer

Study Overview

Nab-Paclitaxel Plus Gemcitabine Versus Gemcitabine For The First Line Treatment of Pancreas Cancer

This is a randomized, multicenter, phase II study of with nab-paclitaxel plus gemcitabine or gemcitabine alone for the treatment of chemotherapy-naïve patients with locally advanced or metastatic pancreatic cancer. Arm 1: Nab-paclitaxel plus gemcitabine Arm 2: Gemcitabine alone Arm 1: Nab-paclitaxel 125 mg/m2 as 30- to 40-minute infusion (maximum infusion time not to exceed 40 minutes) once weekly for 3 weeks followed by a week of rest. plus Gemcitabine 1000 mg/m2 as a 30- to 40-minute infusion (maximum 40 minutes) once weekly for 3 weeks followed by a week of rest. OR Arm 2: Gemcitabine 1000 mg/m2 as a 30- to 40-minute infusion (maximum 40 minutes) administered weekly for 7 weeks followed by a week of rest (8-week cycle; cycle 1 only), followed by cycles of weekly administration for 3 weeks (on days 1, 8, and 15) followed by one week of rest (4-week cycle). All patients will be considered for available second-line therapies or best supportive care on the discretion of the investigators.

Pancreatic Neoplasm

DRUG: Nab-paclitaxel
DRUG: Gemcitabine

AX-PANC-SY001

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2019-01-08	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2019-01-16
First Submitted that Met QC Criteria 2019-01-16	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2019-01-17
First Posted (ACTUAL) 2019-01-17	Results First Posted N/A	Last Verified 2019-01

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
ACTIVE_COMPARATOR: Nab-paclitaxel + Gemcitabine Nab-paclitaxel 125 mg/m2 as 30- to 40-minute infusion (maximum infusion time not to exceed 40 minutes) once weekly for 3 weeks followed by a week of rest. plus Gemcitabine 1000 mg/m2 as a 30- to 40-minute infusion (maximum 40 minutes) once weekly for 3 we	DRUG: Nab-paclitaxel DRUG: Gemcitabine
EXPERIMENTAL: Gemcitabine Gemcitabine 1000 mg/m2 as a 30- to 40-minute infusion (maximum 40 minutes) administered weekly for 7 weeks followed by a week of rest (8-week cycle; cycle 1 only), followed by cycles of weekly administration for 3 weeks (on days 1, 8, and 15) followed by	DRUG: Nab-paclitaxel DRUG: Gemcitabine

Participant Group/Arm

Intervention/Treatment

ACTIVE_COMPARATOR: Nab-paclitaxel + Gemcitabine

Nab-paclitaxel 125 mg/m2 as 30- to 40-minute infusion (maximum infusion time not to exceed 40 minutes) once weekly for 3 weeks followed by a week of rest. plus Gemcitabine 1000 mg/m2 as a 30- to 40-minute infusion (maximum 40 minutes) once weekly for 3 we

DRUG: Nab-paclitaxel

DRUG: Gemcitabine

EXPERIMENTAL: Gemcitabine

Gemcitabine 1000 mg/m2 as a 30- to 40-minute infusion (maximum 40 minutes) administered weekly for 7 weeks followed by a week of rest (8-week cycle; cycle 1 only), followed by cycles of weekly administration for 3 weeks (on days 1, 8, and 15) followed by

DRUG: Nab-paclitaxel

DRUG: Gemcitabine

Primary Outcome Measures	Measure Description	Time Frame
3-months deterioration-free rate	EORTC QLQ-C30 (validated version for Turkish using a reduction of at least 10 points as a meaningful clinical difference) will be used to calculate "time until definitive deterioration" (TUDD) and compare patients receiving first-line Nab-Paclitaxel plus Gemcitabine versus first-line gemcitabine for metastatic or locally advanced unresectable adenocarcinoma of the pancreas. EORTC QLQ-C30 scores will be calculated every four weeks following the EORTC QLQ-C30 recommendations for calculations and scoring (EORTC QLQ- C30 published manual).	From first dose of therapy to third month of therapy, 3 months

Secondary Outcome Measures	Measure Description	Time Frame
Overall Survival		From first dose to death or end of the therapy, 24 months

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Total serum bilirubin <2 mg/dl.
ALP/GGT <5 x ULN.
Transaminases ALT/AST ≤ 2.5 x ULN.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Celgene

Investigators

PRINCIPAL_INVESTIGATOR: Suayib Yalcin, Hacettepe University

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Yalcin S, Dane F, Oksuzoglu B, Ozdemir NY, Isikdogan A, Ozkan M, Demirag GG, Coskun HS, Karabulut B, Evrensel T, Ustaoglu MA, Ozdemir F, Turna H, Yavuzsen T, Aykan F, Sevinc A, Akbulut H, Yuce D, Hayran M, Kilickap S. Quality of life study of patients with unresectable locally advanced or metastatic pancreatic adenocarcinoma treated with gemcitabine+nab-paclitaxel versus gemcitabine alone: AX-PANC-SY001, a randomized phase-2 study. BMC Cancer. 2020 Mar 30;20(1):259. doi: 10.1186/s12885-020-06758-9.

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Resources

Patients

Caregivers

Clinical Trial Record