Trials / Completed

CompletedNCT03807999

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

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
Phase: Phase 2
Study type: Interventional
Enrollment: 125 (actual)

Sponsor: Hacettepe University · Academic / Other
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

Summary

Detailed 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.

Conditions

Pancreatic Neoplasm

Interventions

Type	Name	Description
DRUG	Nab-paclitaxel
DRUG	Gemcitabine

Timeline

Start date: 2015-02-19
Primary completion: 2018-04-01
Completion: 2018-11-01
First posted: 2019-01-17
Last updated: 2019-01-17

Source: ClinicalTrials.gov record NCT03807999. Inclusion in this directory is not an endorsement.