A Multicenter Trial to Evaluate 18F-FDG Uptake by PET in Patients With Advanced Pancreatic Adenocarcinoma as an Early Indicator of Drug Activity

Merck Sharp & Dohme LLC0 sites15 target enrollmentJuly 2010

ConditionsAdvanced Pancreatic Adenocarcinoma

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Advanced Pancreatic Adenocarcinoma
Sponsor: Merck Sharp & Dohme LLC
Enrollment: 15
Primary Endpoint: Association of changes in FDG uptake with overall survival (OS)
Status: Terminated
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

July 2010

End Date

May 2012

Last Updated

10 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Merck Sharp & Dohme LLC

Responsible Party

Sponsor

Eligibility 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

Outcomes

Primary Outcomes

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

Secondary Outcomes

Association of metabolic response with OS(Baseline, Week 3, and at least 7 months after the last patient is treated)
Correlation between FDG standardized uptake values (SUV) at Week 3 and Week 6-7(Week 3 and Week 6-7)