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Phase I Study of CellCept for Advanced Pancreatic Cancer

Phase 1
18 Years
70 Years
Not Enrolling
Pancreatic Cancer

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Trial Information

Phase I Study of CellCept for Advanced Pancreatic Cancer

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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Identification of maximum tolerated dose of CellCept in patients with advanced pancreatic cancer

Outcome Time Frame:

8 weeks

Safety Issue:


Principal Investigator

Robert L Fine, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Columbia University


United States: Food and Drug Administration

Study ID:




Start Date:

June 2004

Completion Date:

January 2009

Related Keywords:

  • Pancreatic Cancer
  • Pancreatic Neoplasms



Columbia University Medical Center New York, New York  10032