Previously Treated Metastatic Pancreatic Cancer Clinical Trial
Official title:
Stand Up to Cancer Consortium: Phase II Study of Therapy Selected by Molecular/Metabolic Profiling in Patients With Previously Treated With Metastatic Pancreatic Cancer
The purpose of the study is selecting second line therapy for patients with pancreatic cancer using molecular profiling will improve 1 year survival.
Following first-line therapy with a gemcitabine based regimen, a significant number of
patients will maintain an adequate performance status and be able to tolerate a second-line
therapy. A recent phase III trial randomized patients to either 5-flurouracil (5FU), folinic
acid or to the addition of weekly oxaliplatin to the same regimen of 5FU/folinic acid. The
interim results showed a statistically significant survival advantage for the oxaliplatin
containing arm (26 versus 13 weeks, P= 0.014). However the outcome of patients who have
progressed on a first-line gemcitabine regimen is still poor with median survival of about
2-6 months.
Almost all patients with advanced APC, treated with gemcitabine alone or a gemcitabine based
combination therapy will exhibit resistance to therapy. In patients treated with gemcitabine
alone, the time to progression (TTP) is about 3-4 months. Thus most patients will exhibit
progression and /or toxicity and will require second line therapy at 4-6 months into first
line therapy. The best one year survival reported in a phase II trial is only 24%. However
there is no standard second line therapy for APC, a rapid progression of tumor is seen in
this setting, and new strategies based on rational target identification are needed. In this
study we propose to select therapy based on the molecular profiling of each patients tumor.
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Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment