Trial Information

Summary: Phase I Study of CellCept (Mycophenolate Mofetil) for Advanced Pancreatic Cancer Phase

This is a nonrandomized Phase I study of CellCept (Mycophenolate Mofetil) in patients with advanced pancreatic cancer who have failed at least one prior regimen of chemotherapy. While Gemzar (gemcitabine) remains the current single agent of choice for advanced pancreatic cancer, there is a great need to investigate and discover new treatments which utilize the latest discoveries of the molecular biology of pancreatic cancer. The use of CellCept (Mycophenolate Mofetil) has a rationale for use based upon its ease of use and tolerability, its effects on cell purine metabolism, and in vitro laboratory data showing effective cell killing of pancreatic cancer cells at concentrations comparable to those clinically achieved in patients.

Patients must fulfill the following 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 two prior regimens)
  • >3 weeks since last chemotherapy
  • >3 weeks since surgery
  • =4 weeks since radiation therapy
• Non-pregnant, non-lactating women with a negative serum a-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 = ECOG 0-2
• HIV negative or never tested

• Required initial laboratory data

• White cell count =3000 cells/µl
• Platelet count =100,000 platelets/µl
• BUN =1.5x UL normal
• Creatinine =1.5x UL normal
• Total Bilirubin =3.0 mg/dl
• AST, ALT =3.0x UL normal
• Alkaline Phosphatase =3.0x UL normal
• 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.

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Trial listings updated: June 1, 2008 at 5:45:15 AM