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Phase I/II Study to Assess the Efficacy and Safety of Nab-paclitaxel in Combination With Gemcitabine for the Treatment of Fragile Patients With Advanced or Metastatic Pancreatic Cancer
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Complexo Hospitalario Universitario A Coruña
A Coruña, A Coruña, Spain
Complexo Hospitalario Universitario de Santiago
Santiago de Compostela, A Cosuña, Spain
Hospital Universitari Vall D'Hebron
Barcelona, Barcelona, Spain
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria, Spain
Hospital Universitario Donostia
Donostia / San Sebastian, Gipuzkoa, Spain
Complejo Hospitalario Regional Virgen de Las Nieves
Granada, Granada, Spain
Complejo Hospitalario Gregorio Marañón
Madrid, Madrid, Spain
Hospital Ramón Y Cajal
Madrid, Madrid, Spain
Hospital Clínico San Carlos
Madrid, Madrid, Spain
Hospital Universitario Fundación Jiménez Díaz
Madrid, Madrid, Spain
Start Date
April 1, 2013
Primary Completion Date
April 1, 2016
Completion Date
April 1, 2016
Last Updated
July 6, 2016
224
ACTUAL participants
Nab-paclitaxel 150 mg/m2 + Gemcitabine 1000 weeks 1,3/4
DRUG
Nab-paclitaxel 100 mg/m2 + Gemcitabine 1000 weeks 1,2,3/4
DRUG
Nab-paclitaxel 125 mg/m2 + Gemcitabine 1000 weeks 1,3/4
DRUG
Nab-paclitaxel 125 mg/m2 + Gemcitabine 1000 weeks 1,2,3/4
DRUG
Lead Sponsor
PH Research, S.L.
NCT03652428
NCT05098197
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT05975593