Advertisement

Topics

MK0752 and Gemcitabine Hydrochloride in Treating Patients With Stage IV Pancreatic Cancer That Cannot Be Removed by Surgery

2014-07-23 21:09:39 | BioPortfolio

Summary

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.

Description

OBJECTIVES:

Primary

- 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.

Secondary

- 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.

Tertiary

- 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

Study Design

Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment

Conditions

Pancreatic Cancer

Intervention

MK0752, gemcitabine hydrochloride, imaging biomarker analysis, laboratory biomarker analysis, pharmacological study, fludeoxyglucose F 18

Location

Addenbrooke's Hospital
Cambridge
England
United Kingdom
CB2 2QQ

Status

Recruiting

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:09:39-0400

Clinical Trials [4553 Associated Clinical Trials listed on BioPortfolio]

ABT-888 and Gemcitabine Hydrochloride in Treating Patients With Advanced Solid Tumors

RATIONALE: ABT-888 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 differe...

GDC-0449 and Erlotinib Hydrochloride With or Without Gemcitabine Hydrochloride in Treating Patients With Metastatic Pancreatic Cancer or Solid Tumors That Cannot Be Removed by Surgery

RATIONALE: Drugs used in chemotherapy, such as GDC-0449 and gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping ...

Vismodegib and Gemcitabine Hydrochloride in Treating Patients With Advanced Pancreatic Cancer

This pilot clinical trial studies vismodegib and gemcitabine hydrochloride in treating patients with advanced pancreatic cancer. Vismodegib may stop the growth of pancreatic cancer by bloc...

Brentuximab Vedotin and Gemcitabine Hydrochloride in Treating Younger Patients With Relapsed or Refractory Hodgkin Lymphoma

This phase I/II trial studies the side effects and the best dose of brentuximab vedotin when given together with gemcitabine hydrochloride and to see how well they work in treating younger...

Buparlisib, Gemcitabine Hydrochloride, and Cisplatin in Treating Patients With Advanced Solid Tumors

This phase I trial studies the side effects and the best doses of buparlisib, gemcitabine hydrochloride, and cisplatin in treating patients with solid tumors that have spread to other plac...

PubMed Articles [22773 Associated PubMed Articles listed on BioPortfolio]

Simultaneous quantification of Gemcitabine and Irinotecan hydrochloride in rat plasma by using high performance liquid chromatography-diode array detector.

In this manuscript we aimed at the simultaneous separation and quantification of Gemcitabine and Irinotecan hydrochloride (injected both as single components and in combination) from Sprague Dawley ra...

ADC at 3.0 T as a noninvasive biomarker for preoperative prediction of Ki67 expression in invasive ductal carcinoma of breast.

To investigate the role of apparent diffusion coefficient (ADC) as an imaging biomarker for invasive ductal carcinoma (IDC) in the breast.

Biomatrix for upper and lower airway biomarker in allergic asthma.

Comprehensive analysis of biomarkers in upper and lower airways revealed greatest relation to lower airway biomarker specifically IL-24. All other biomarker candidates showed weak to moderate correlat...

Peripheral Blood miR-139 May Serve as a Biomarker for Metabolic Disorders by Targeting FoxO1 and FoxP1.

The current study mainly evaluated whether peripheral blood miR-139 could be used as a biomarker to screen patients with metabolic disorders.

Biomarker assessment of the CBCSG006 trial: A randomized phase III trial of cisplatin plus gemcitabine compared with paclitaxel plus gemcitabine as first-line therapy for patients with metastatic triple-negative breast cancer.

CBCSG006 trial reported the superior efficacy of cisplatin plus gemcitabine (GP) regimen than paclitaxel plus gemcitabine (GT) regimen as first-line treatment of metastatic triple-negative breast canc...

Medical and Biotech [MESH] Definitions

The N-glucuronide conjugate of cotinine is a major urinary metabolite of NICOTINE. It thus serves as a biomarker of exposure to tobacco SMOKING. It has CNS stimulating properties.

A small cytosolic fatty-acid binding protein that forms a lipid-binding beta-barrel structure and is expressed by CARDIOMYOCYTES and at lower levels in brain tissue. It is released into plasma immediately following cardiac injury and may therefore serve as a useful biomarker for the early detection of MYOCARDIAL INFARCTION.

The use of molecularly targeted imaging probes to localize and/or monitor biochemical and cellular processes via various imaging modalities that include RADIONUCLIDE IMAGING; ULTRASONOGRAPHY; MAGNETIC RESONANCE IMAGING; fluorescence imaging; and MICROSCOPY.

C-type lectins that restrict growth of bacteria in the intestinal epithelia and have bactericidal activity against gram-positive and gram-negative bacteria. They also regulate proliferation and differentiation of KERATINOCYTES following injury. Human pancreatitis-associated protein-1 (Reg3a) is overexpressed by pancreatic ACINAR CELLS in patients with CHRONIC PANCREATITIS. It is also highly expressed by pancreatic, bladder, and gastrointestinal cancer cells and may serve as a diagnostic biomarker.

Analysis based on the mathematical function first formulated by Jean-Baptiste-Joseph Fourier in 1807. The function, known as the Fourier transform, describes the sinusoidal pattern of any fluctuating pattern in the physical world in terms of its amplitude and its phase. It has broad applications in biomedicine, e.g., analysis of the x-ray crystallography data pivotal in identifying the double helical nature of DNA and in analysis of other molecules, including viruses, and the modified back-projection algorithm universally used in computerized tomography imaging, etc. (From Segen, The Dictionary of Modern Medicine, 1992)

More From BioPortfolio on "MK0752 and Gemcitabine Hydrochloride in Treating Patients With Stage IV Pancreatic Cancer That Cannot Be Removed by Surgery"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Clincial Trials
In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...

Pancreatitis
Pancreatitis Acute pancreatitis is inflammation of the pancreas caused by the release of activated pancreatic enzymes. Common triggers are biliary tract disease and chronic heavy alcohol intake.  Diagnosis is based on clinical presentation...


Searches Linking to this Trial