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

Pancreatic Neoplasm Clinical Trial

Official title: Nab-Paclitaxel Plus Gemcitabine Versus Gemcitabine For The First Line Treatment of Metastatic or Locally Advanced Unresectable Adenocarcinoma of The Pancreas: A Phase II Randomized Study

Status Completed

Clinical Trial Summary

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

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• Pancreatic Neoplasm
• Pancreatic Neoplasms

• NCT number: NCT03807999
• Study type: Interventional
• Source: Hacettepe University
• Status: Completed
• Phase: Phase 2
• Start date: February 19, 2015
• Completion date: November 1, 2018