First-line Treatment of Metastatic Pancreatic Cancer With Nab-paclitaxel and Gemcitabine

PHASE2CompletedINTERVENTIONAL
Enrollment

325

Participants

Timeline

Start Date

December 31, 2016

Primary Completion Date

March 31, 2022

Study Completion Date

May 31, 2022

Conditions
Metastatic Pancreatic CancerAdenocarcinoma of the Pancreas
Interventions
DRUG

nab-paclitaxel and gemcitabine

"Induction treatment:~3 cycles nab-paclitaxel and gemcitabine 125 mg/m\^2, IV infusion over 30 minutes, followed by gemcitabine 1000 mg/m\^2 as a 30-minute IV infusion; D1, D8, D15 of each 28-day cycle.~Continouous treatment after randomization:~Continuing application of nab-paclitaxel and gemcitabine treatment cycles until progression or unacceptable toxicity. Duration of each cycle is 28 days nab-paclitaxel 125 mg/m\^2, IV infusion over 30 minutes, followed by gemcitabine 1000 mg/m\^2 as a 30-minute IV infusion; D1, D8, D15 of each 28-day cycle."

DRUG

gemcitabine mono and nab-paclitaxel and gemcitabine

"Induction treatment:~3 cycles nab-paclitaxel and gemcitabine 125 mg/m\^2, IV infusion over 30 minutes, followed by gemcitabine 1000 mg/m\^2 as a 30-minute IV infusion; D1, D8, D15 of each 28-day cycle.~Continouous treatment after randomization:~Alternating application of gemcitabine monotherapy and nab-paclitaxel and gemcitabine treatment cycles until progression or unacceptable toxicity, starting with a treatment cycle of gemcitabine monotherapy.~Duration of each cycle irrespective of treatment cycle with gemcitabine monotherapy or treatment with nab-paclitaxel/gemcitabine is 28 days.~Gemcitabine monotherapy treatment cycle: Gemcitabine 1000 mg/m\^2 as a 30-minute IV infusion; D1, D8, D15 of each 28-day cycle.~Nab-paclitaxel and gemcitabine treatment cycle: Nab-paclitaxel 125 mg/m\^2, IV infusion over 30 minutes, followed by gemcitabine 1000 mg/m\^2 as a 30-minute IV infusion; D1, D8, D15 of each 28-day cycle."

Trial Locations (1)

92637

Kliniken Nordoberpfalz AG, Klinikum Weiden, Weiden

Sponsors
All Listed Sponsors
collaborator

ClinAssess GmbH

INDUSTRY

collaborator

Celgene Corporation

INDUSTRY

lead

AIO-Studien-gGmbH

OTHER