Advanced Pancreatic Cancer Clinical Trial
Official title:
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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