This trial remains active but is no longer recruiting.
In a clinical trial researchers are comparing the standard post-surgery chemotherapy with another treatment regimen, in patients whose cancer has not spread beyond the pancreas. Typically, patients receive chemotherapy with gemcitabine after surgery to kill any residual tumor cells.
A Changed Plan
This trial was originally designed to compare the effectiveness of standard gemcitabine treatment with three different treatment options. It was divided into two phases, each with two trial arms comparing different treatments.
Participants were randomly assigned to receive one of the three options. In the phase II section of the trial, participants were assigned to either of two trial arms. In arm 1, patients received gemcitabine (standard chemotherapy), while in arm 2 patients received gemcitabine plus erlotinib.
Erlotinib is a receptor kinase inhibitor and like gemcitabine, it prevents cancer cells from multiplying. Gemcitabine is converted into two metabolites that cause cell death. One reduces the number of building blocks necessary to make DNA; the other shortens the DNA strands. Erlotinib slows the spread of cancer by blocking signaling that tells cancer cells to grow.
As the trial progressed researchers found that the erlotinib and gemcitabine combination was not effective. That part of the trial was suspended.
The Current Trial
The phase III arm of the trial continues. It compares standard treatment with radiation plus either capecitabine (brand name Xeloda, given in pill form) or fluorouracil (5-FU, given intravenously). Capecitabine gets metabolized into 5-FU; in either form the drug disrupts the cell replication cycle. Participants assigned to this part of the trial receive either gemcitabine (or standard chemotherapy) with or without radiation and capecitabine/5-FU.
We encourage you to consult your physicians for clinical trials that may be right for you. The website ClinicalTrials.gov provides details about many trials. You can visit the Clinical Trial Finder for a listing of this trial and all active pancreatic cancer clinical trials.