Nab-paclitaxel in Combination With Gemcitabine in Fragile Patients With Advanced Pancreatic Cancer

Summary

In the list of cancer mortality by type of cancer pancreatic cancer ranks 4th in USA and the 6th in Europe. The estimated figures for 2010 in the USA were 42,000 new cases and 36,000 deaths from pancreatic cancer. The survival rate at 5 years after diagnosis is 4.6% in the USA. In Europe the figures are similar, with survival at 1, 3 and 5 years of 16%, 6% and 4%, respectively. Most patients are diagnosed in advanced stages that are no longer operable, so that treatment goals are often the prolongation of survival and palliation of symptoms.

The aim of the study is to explore whether the new combination nab-paclitaxel plus gemcitabine is a therapeutic advance for this fragile population for which it is assumed that some modifications in dose and schedule of administration may be necessary in patients with good performance status. It is ultimately to find out the clinical benefit of this combination, but first making sure that dose and schedule of the combination are tolerable for these fragile patients.

For this, the investigators have chosen a design that includes two stages: the first step aimed at choosing the safest treatment regimen for these patients among a group of treatment regimens used in other clinical trials. The second step will evaluate the effectiveness of the two regimens with the better results in the previous step.

Conditions

• Advanced Pancreatic Cancer

Interventions

DRUG

Nab-paclitaxel 150 mg/m2 + Gemcitabine 1000 weeks 1,3/4

Nab-paclitaxel 150 mg/m2 + Gemcitabine 1000 days 1 \& 15 in a 28 days cycle

DRUG

Nab-paclitaxel 100 mg/m2 + Gemcitabine 1000 weeks 1,2,3/4

Nab-paclitaxel 100 mg/m2 + Gemcitabine 1000 days 1,8 \& 15 in a 28 days cycle

DRUG

Nab-paclitaxel 125 mg/m2 + Gemcitabine 1000 weeks 1,3/4

Nab-paclitaxel 125 mg/m2 + Gemcitabine 1000 days 1 \& 15 in a 28 days cycle

DRUG

Nab-paclitaxel 125 mg/m2 + Gemcitabine 1000 weeks 1,2,3/4

Nab-paclitaxel 125 mg/m2 + Gemcitabine 1000 days 1,8 \& 15 in a 28 days cycle

Sponsors & Collaborators

• PH Research, S.L.

  lead OTHER

Principal Investigators

• Manuel Hidalgo, MD · Hospital Universitario Madrid Sanchinarro

• Fernando Rivera, MD · HOSPITAL UNIVERSITARIO MARQUÉS DE VELDECILLA

• Teresa Macarulla, MD · Hospital Vall d'Hebron

• Carmen Guillén, MD · Hospital Universitario Ramon y Cajal

• Rafael López, MD · COMPLEXO HOSPITALARIO UNIVERSITARIO DE SANTIAGO

• Roberto Pazo, MD · Hospital Miguel Servet

• Manuel Valladares, MD · COMPLEXO HOSPITALARIO UNIVERSITARIO A CORUÑA

• Roberto P Díaz, MD · Hospital Universitario La Fe

• Inmaculada Alés, MD · COMPLEJO HOSPITALARIO REGIONAL DE MÁLAGA

• Joaquina Martínez, MD · COMPLEJO HOSPITALARIO REGIONAL VIRGEN DE LAS NIEVES

• Adelaida La Casta, MD · Hospital Donostia

• Rut Vera, MD · Complejo Hospitalario de Navarra

• Andrés Muñoz, MD · COMPLEJO HOSPITALARIO GREGORIO MARAÑÓN

• José I Martín, MD · HOSPITAL UNIVERSITARIO FUNDACIÓN JIMÉNEZ DIAZ

• Javier Sastre, MD · Hospital San Carlos, Madrid

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-04-30

Primary Completion

2016-04-30

Completion

2016-04-30

Countries

• Spain

Study Locations