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Study of CellCept for Advanced Pancreatic Cancer

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ClinicalTrials.gov Identifier: NCT00997958
Recruitment Status : Completed
First Posted : October 20, 2009
Last Update Posted : April 25, 2014
Sponsor:
Information provided by (Responsible Party):
Robert L. Fine, Columbia University

Tracking Information
First Submitted Date  ICMJE October 14, 2009
First Posted Date  ICMJE October 20, 2009
Last Update Posted Date April 25, 2014
Study Start Date  ICMJE June 2004
Actual Primary Completion Date October 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 16, 2009)
Identification of maximum tolerated dose of CellCept in patients with advanced pancreatic cancer [ Time Frame: 8 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00997958 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of CellCept for Advanced Pancreatic Cancer
Official Title  ICMJE Phase I Study of CellCept for Advanced Pancreatic Cancer
Brief Summary 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 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Pancreatic Cancer
Intervention  ICMJE 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).

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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 16, 2009)
12
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2009
Actual Primary Completion Date October 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00997958
Other Study ID Numbers  ICMJE AAAA1127
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Robert L. Fine, Columbia University
Study Sponsor  ICMJE Columbia University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Robert L Fine, MD Columbia University
PRS Account Columbia University
Verification Date April 2014

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