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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
224
Nab-paclitaxel 150 mg/m2 + Gemcitabine 1000 days 1 \& 15 in a 28 days cycle
Nab-paclitaxel 100 mg/m2 + Gemcitabine 1000 days 1,8 \& 15 in a 28 days cycle
Nab-paclitaxel 125 mg/m2 + Gemcitabine 1000 days 1 \& 15 in a 28 days cycle
Nab-paclitaxel 125 mg/m2 + Gemcitabine 1000 days 1,8 \& 15 in a 28 days cycle
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
...and 5 more locations
PHASE I: To select the schemes with the best therapeutic indexes of the combination of gemcitabine and nab-paclitaxel in fragile patients with advanced pancreatic cancer.
Phase I: Therapeutic index. Criteria: Early mortality all causes at 30 and 60 days, Adverse Events grade 3 and 4, treatment discontinuation due to toxicity and relative dose intensity
Time frame: Up to 2 months
PHASE II: Evaluate the effectiveness of two selected schemes of gemcitabine and nab-paclitaxel, vs. gemcitabine alone. (Six months overall survival)
Six months overall survival
Time frame: Up to 6 months
Phase I: evaluate safety profile of gemcitabine and nab-paclitaxel schemes. (Number of events per patient according to NCI-CTC-AE criteria)
Number of events per patient according to NCI-CTC-AE criteria
Time frame: Up to 6 months
Phase I: evaluate objective response rate. (Response rate will be evaluated according RECIST criteria)
Response rate will be evaluated according RECIST criteria
Time frame: Up to 6 months
Phase II: progression free survival (Time from randomization to disease progression according RECIST criteria)
Time from randomization to disease progression according RECIST criteria
Time frame: Up to 8 months
Phase II: objective response rate (Response rate will be evaluated according RECIST criteria)
Response rate will be evaluated according RECIST criteria
Time frame: Up to 6 months
Phase II: to explore changes induced by treatment on tumor Marker CA19.9
Time frame: Up to 8 months
Phase II: change in FAP and Cav-1 tumor markers as an inidicatior of treatment efficacy
Time frame: Up to 6 months
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