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Study of CellCept for Advanced Pancreatic Cancer

Primary Purpose

Pancreatic Cancer

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Mycophenolate mofetil

About this trial

This is an interventional treatment trial for Pancreatic Cancer

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Columbia University Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CellCept

Arm Description

Administered in tablet form twice daily one hour after eating.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT00997958

First Posted

October 14, 2009

Last Updated

April 24, 2014

Sponsor

Columbia University

1. Study Identification

Unique Protocol Identification Number

NCT00997958

Brief Title

Study of CellCept for Advanced Pancreatic Cancer

Official Title

Phase I Study of CellCept for Advanced Pancreatic Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

April 2014

Overall Recruitment Status

Completed

Study Start Date

June 2004 (undefined)

Primary Completion Date

October 2007 (Actual)

Study Completion Date

January 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Columbia University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pancreatic Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

12 (Actual)

8. Arms, Groups, and Interventions

Arm Title

CellCept

Arm Type

Experimental

Arm Description

Administered in tablet form twice daily one hour after eating.

Intervention Type

Drug

Intervention Name(s)

Mycophenolate mofetil

Intervention Description

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 Measure Information:

Title

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

Time Frame

8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Robert L Fine, MD

Organizational Affiliation

Columbia University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Columbia University Medical Center

City

New York

State/Province

New York

ZIP/Postal Code

10032

Country

United States

12. IPD Sharing Statement

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Study of CellCept for Advanced Pancreatic Cancer

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