Pancreatic Cancer Research

Clinical trialPhase 1Completed

Study of CellCept for Advanced Pancreatic Cancer

Phase I Study of CellCept for Advanced Pancreatic Cancer

Outcome
Finished, no results posted
Phase
Phase 1
Status
Completed
Study type
Interventional
Start
June 2004
Expected end
January 2009
Enrollment
12 participants
Sites
1
Primary outcomes
Identification of maximum tolerated dose of CellCept in patients with advanced pancreatic cancer
Sponsor
Other
Results posted
No
Last update
25 April 2014

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Brief summary public domain (ClinicalTrials.gov)

Mycophenolate Mofetil (CellCept) is an FDA approved, well tolerated, oral medication used to prevent the body's immune system from attacking transplanted organs. It has never been studied in patients with pancreatic cancer but some preliminary studies have shown that it may antagonize tumor growth. The goals of this study are to find out how much of this drug can safely be taken by patients with advanced pancreatic cancer and to assess the variation of the level of the drug in the blood. Patients will take the drug twice a day at a given dose and the safety of the drug will be monitored through patient symptoms and blood tests. The disease burden will be assessed by radiographic studies at the beginning and end of the study. The patient will take the drug for a total of eight weeks.

Detailed description public domain (ClinicalTrials.gov)

Mycophenolate Mofetil (CellCept) is a prodrug whose active metabolite, mycophenolic acid (MPA), acts as an immune suppressant by inhibiting de novo guanosine synthesis. CellCept is FDA approved to prevent rejection of transplanted organs. It is well tolerated, orally dosed, and has some known antitumor effects. It has never been studied in pancreatic cancer and the maximum tolerated dose is not known. In vitro studies in our lab with human pancreatic cancer lines found that MPA was a potent inhibitor of pancreatic cancer cell growth and induced apoptosis. The objectives of this study are to identify the maximum tolerated dose of CellCept in patients with advanced pancreatic cancer that have failed at least two prior chemotherapy regimens and assess its pharmacokinetics.