Study of CellCept for Advanced Pancreatic Cancer
Completed · Phase 1
Conditions studied: Pancreatic Cancer
In brief
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.
Key facts
- Study ID
- NCT00997958
- Run by
- Columbia University
- People needed
- 12
- Starts
- 2004-06-01
- Expected to finish
- 2009-01-01
- Last updated by the study team
- 2014-04-25
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
Where it is running
- Columbia University Medical Center — New York, New York, United States
Full record on ClinicalTrials.gov
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