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

Advanced Pancreatic Adenocarcinoma Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01050283
• Other study ID #: 0000-144
• Secondary ID: 144
• Status: Terminated
• Phase: Phase 1
• First received: January 13, 2010
• Last updated: July 24, 2015
• Start date: July 2010
• Est. completion date: May 2012

Study information

• Verified date: July 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Adenocarcinoma
• Advanced Pancreatic Adenocarcinoma

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Association of changes in FDG uptake with overall survival (OS)		Week 3 and at least 7 months after the last patient is treated	No
Secondary	Association of metabolic response with OS		Baseline, Week 3, and at least 7 months after the last patient is treated	No
Secondary	Correlation between FDG standardized uptake values (SUV) at Week 3 and Week 6-7		Week 3 and Week 6-7	No