Study of CellCept for Advanced Pancreatic Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Robert L. Fine, Columbia University
ClinicalTrials.gov Identifier:
NCT00997958
First received: October 14, 2009
Last updated: April 24, 2014
Last verified: April 2014

October 14, 2009
April 24, 2014
June 2004
October 2007   (final data collection date for primary outcome measure)
Identification of maximum tolerated dose of CellCept in patients with advanced pancreatic cancer [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00997958 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Study of CellCept for Advanced Pancreatic Cancer
Phase I 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.

Interventional
Phase 1
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Pancreatic Cancer
Drug: Mycophenolate mofetil

Dose escalation increasing successively from 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, and 5.0 grams p.o. bid.

Each patient will be treated for eight weeks (56 days).

Experimental: CellCept
Administered in tablet form twice daily one hour after eating.
Intervention: Drug: Mycophenolate mofetil
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
January 2009
October 2007   (final data collection date for primary outcome measure)

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.
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00997958
AAAA1127
Yes
Robert L. Fine, Columbia University
Columbia University
Not Provided
Principal Investigator: Robert L Fine, MD Columbia University
Columbia University
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP