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RATIONALE: MK0752 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving MK0752 together with gemcitabine hydrochloride may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of giving MK0752 together with gemcitabine hydrochloride and to see how well it works in treating patients with stage IV pancreatic cancer that cannot be removed by surgery.
- To determine the recommended phase II dose of MK0752 in combination with gemcitabine hydrochloride in patients with unresectable stage IV pancreatic cancer.
- To determine the safety and tolerability of this regimen in these patients.
- To assess survival at 6 months.
- To evaluate tumor response in patients treated with this regimen.
- To determine the time to disease progression and 1-year survival.
- To determine the percentage of change in CA19-9 levels.
- To determine the pharmacokinetic profile of MK0752 in plasma when administered with and without gemcitabine hydrochloride.
- To assess target inhibition by MK0752.
- To explore the feasibility of measuring MK0752 levels in tumor tissue.
- To establish relationships between measures of tumor expression of molecular target and objective tumor response.
- To determine the potential for noninvasive imaging using fludeoxyglucose F 18 positron emission tomography/computed tomography scans as a marker of response to MK0752.
OUTLINE: This is a multicenter, phase I, dose-escalation study of MK0752 and gemcitabine hydrochloride followed by an open-label, phase II study.
Patients receive gemcitabine hydrochloride IV on days 1, 8, and 15. Patients receive oral MK0752 on days -14, -7, 1, 8, 15, and 22 in course 1 only and on days 1, 8, 15, and 22 beginning in course 2 and for all subsequent courses. Treatment with MK0752 and gemcitabine hydrochloride repeats every 28 days* for 6 courses in the absence of disease progression or unacceptable toxicity. Patients also undergo fludeoxyglucose F 18 PET/CT scans at baseline and during study to measure changes in tumor uptake.
NOTE: *The first course is 42 days.
Patients undergo biopsy of tumor at baseline and on day -7. Tumor samples are analyzed to determine Notch pathway inhibition via IHC and qualitative RT-PCR analysis and for MK0752 concentrations. Hair follicle (from the head) samples are collected at baseline and on day -7 to determine Notch pathway inhibition via RT-PCR. Blood samples are collected periodically to determine changes in CA 19-9 levels and MK0752 concentrations.
After completion of study treatment, patients are followed for 28 days and then every 2 months for 1 year.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment
MK0752, gemcitabine hydrochloride, imaging biomarker analysis, laboratory biomarker analysis, pharmacological study, fludeoxyglucose F 18
National Cancer Institute (NCI)
Published on BioPortfolio: 2014-07-23T21:09:39-0400
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