A Study to Evaluate [18F]-FDG PET (Fluorodeoxyglucose-positron) in Patients With Pancreatic Cancer (MK-0000-144)

This study has been terminated.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01050283
First received: January 13, 2010
Last updated: March 5, 2013
Last verified: March 2013
  Purpose

This study will determine whether [18F]-fluorodeoxyglucose-positron emission tomography (FDG-PET) can be used to screen for the activity of novel pancreatic cancer treatments.


Condition Intervention Phase
Advanced Pancreatic Adenocarcinoma
Procedure: Comparator: [18F]-FDG PET/CT and Volumetric CT
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: A Multicenter Trial to Evaluate 18F-FDG Uptake by PET in Patients With Advanced Pancreatic Adenocarcinoma as an Early Indicator of Drug Activity

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Association of changes in FDG uptake with overall survival (OS) [ Time Frame: Week 3 and at least 7 months after the last patient is treated ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Association of metabolic response with OS [ Time Frame: Baseline, Week 3, and at least 7 months after the last patient is treated ] [ Designated as safety issue: No ]
  • Correlation between FDG standardized uptake values (SUV) at Week 3 and Week 6-7 [ Time Frame: Week 3 and Week 6-7 ] [ Designated as safety issue: No ]

Enrollment: 15
Study Start Date: July 2010
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
[18F]-FDG-PET/CT (Computed Tomography) Imaging
Procedure: Comparator: [18F]-FDG PET/CT and Volumetric CT
Patients will receive gemcitabine-based therapy as prescribed by their treating physician. FDG-PET/CT scans will be performed at baseline following enrollment, and after 3 and 6-7 weeks of therapy. Volumetric CT scans will be performed at baseline following enrollment, and after 3 and 6-7 weeks of therapy.

  Eligibility

Ages Eligible for Study:   35 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient has a diagnosis of Stage IV pancreatic adenocarcinoma with distant metastases
  • Patient is scheduled to receive standard chemotherapy containing gemcitabine
  • Patient has not received prior systemic therapy for advanced pancreatic adenocarcinoma
  • Patient must be available for periodic blood sampling, study-related assessments, and management at the treating institution

Exclusion Criteria:

  • Patient has had open abdominal surgery within 6 weeks of the screening visit
  • Patient has had radiotherapy to the thorax, abdomen, or pelvis within 6 months of the screening visit
  • Patient has an active infection, inflammation, or unresolved bowel obstruction
  • Patient has poorly controlled diabetes
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01050283

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Vice President, Late Stage Development Group Leader, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT01050283     History of Changes
Other Study ID Numbers: 2010_501, 144
Study First Received: January 13, 2010
Last Updated: March 5, 2013
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Merck Sharp & Dohme Corp.:
Advanced pancreatic adenocarcinoma

Additional relevant MeSH terms:
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on April 17, 2014