Trial intelligence / Profile preview

Bortezomib +/- Gemcitabine in Metastatic Pancreatic Cancer

NCT00052689Phase 2

Key facts

Status: Completed
Start: Dec 2002
Primary completion: Oct 2007
Countries: 1
Sponsor: National Cancer Institute
Modality: Small Molecules, Modified Peptides

Drugs: bortezomib
Conditions: pancreatic adenocarcinoma (PDAC)

Overview

Phase 2, randomised, open-label trial of bortezomib in pancreatic adenocarcinoma (PDAC) (2 arms), sponsored by National Cancer Institute. Primary endpoints: Confirmed tumor response (CR, PR) rate at 6 months and Proportion of patients alive at 6 months. Started Dec 2002; status: completed.

Design

2 arms

Study design: RandomizedOpen-label

Arm I
Bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Crossover to Arm II upon progression.
Arm II
Bortezomib IV on days 1, 4, 8, and 11 + Gemcitabine IV over 30 minutes on days 1 and 8.

Who it enrols

Patients with previously untreated metastatic pancreatic adenocarcinoma, ECOG 0-2, adequate organ function, and no prior chemotherapy or bortezomib.

Endpoints

Primary

Confirmed tumor response (CR, PR) rate6 months
Proportion of patients alive at 6 months6 months

Secondary

Overall Survival5 years
Progression-Free Survival5 years
Time to treatment failure5 years
Quality of Lifecourse 4
Toxicityup to 5 years

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