Study of CellCept for Advanced Pancreatic Cancer
Study of CellCept for Advanced Pancreatic Cancer
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.
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.
Inclusion Criteria:

 -  Histologically confirmed adenocarcinoma of pancreas.

 -  Disease stage IV, locally advanced and/or metastatic.

 -  Measurable disease: Any mass reproducibly measurable in two perpendicular diameters by
 x-ray, physical examination, CT or MRI scan.

 -  The following lesions conventionally are not considered measurable:

 -  CNS lesions

 -  Blastic or lytic bone lesions (which will be documented and followed)

 -  Radiated lesions unless progression after RT is documented

 -  Ineligible for other high priority national or institutional studies.

 -  Prior therapy allowed:

 -  Chemotherapy (at least one prior regimen)

 -  > 3 weeks since last chemotherapy

 -  > 3 weeks since surgery

 -  ≥ 4 weeks since RT

 -  Non pregnant, non lactating women with a negative serum α-HCG test within one week of
 starting the study, AND

 -  Must be willing to consent to the use of two forms of contraception (at least one
 barrier) if of childbearing potential while on trial and six weeks after CellCept has
 been stopped.

 -  Clinical Parameters:

 -  Life expectancy ≥ 3 months

 -  Age 18 to 70 years

 -  Brain CT or MRI no visible metastases

 -  Performance status 0-2 (ECOG- see appendix B)

 -  HIV negative or never tested

 -  Required initial laboratory data:

 -  Normal

 -  White cell count ≥3000 cells / μl

 -  Platelet count ≥100,000 platelets / μl

 -  BUN ≤1.5 x normal 20 mg/dl

 -  Creatinine ≤1.5 x normal 1.0 mg/dl

 -  Total Bilirubin ≤3.0 mg/dl

 -  AST, ALT ≤3.0 x normal 38 U/L

 -  Alkaline Phosphatase ≤3.0 x normal 96 U/L

 -  Albumin ≥2.5 g/dl

 -  Informed Consent: Each patient must be completely aware of the nature of his/her
 disease process and must willingly give written consent after being informed of the
 procedure to be followed, the experimental nature of the therapy, alternatives,
 potential benefits, adverse effects, risks, and discomforts.

 -  Prior malignancy in last 5 years: The cancer must be curatively treated carcinoma in
 situ of the cervix or skin cancer.

 -  No serious medical or psychiatric illness preventing informed consent or intensive
 treatment (e.g., serious infection).

 -  Absence of concurrent treatment with cholestyramine, acyclovir, cyclosporine, or
 antacids with magnesium or aluminum hydroxides because of their effects on drug
 metabolism and serum levels of MPA.

 -  Absence of active serious digestive system disease as defined at the discretion of the
 Principal Investigator.