Study Of CellCept For Advanced Pancreatic Cancer

Study Overview

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.

Pancreatic Cancer

DRUG: Mycophenolate mofetil

AAAA1127

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2009-10-14	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2014-04-24
First Submitted that Met QC Criteria 2009-10-16	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2014-04-25
First Posted (ESTIMATED) 2009-10-20	Results First Posted N/A	Last Verified 2014-04

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: CellCept Administered in tablet form twice daily one hour after eating.	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).

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: CellCept

Administered in tablet form twice daily one hour after eating.

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).

Primary Outcome Measures	Measure Description	Time Frame
Identification of maximum tolerated dose of CellCept in patients with advanced pancreatic cancer		8 weeks

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Robert L Fine, MD, Columbia University

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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