A Study Of Hypoxia Imaging In Advanced Pancreatic Cancer Patients Being Treated With Gemcitabine And TH-302 Or TH-302 Placebo

Study Overview

A Study of Hypoxia Imaging in Advanced Pancreatic Cancer Patients Being Treated With Gemcitabine and TH-302 or TH-302 Placebo

Researchers are looking for better ways of diagnosing and treating pancreatic cancer. It is believed that looking for low levels of oxygen (hypoxia) in tumours may give a better understanding of how certain tumours grow or respond to certain treatments. This study will look at hypoxia in pancreatic tumours while participants are receiving treatment with the combination of gemcitabine and TH-302/placebo in the EMR 200592-001 clinical research study. This study will use positron emission tomography (PET) scans to look at hypoxia in tumours. PET is an imaging test that can be used to measure hypoxia in tumours. For this study, a radioactive tracer called Fluoroazomycin Arabinoside (FAZA) will be used to "label" areas of hypoxia in tumours. Determining the levels of hypoxia in tumour tissue using FAZA-PET scans and comparing these levels with the patient's response to treatment with gemcitabine and TH-302/placebo for pancreatic cancer may help the researchers to determine the relationship between hypoxia and response to this treatment. The main purpose of this study is to see how useful looking at hypoxia in tumours are when they are done at different centres.

N/A

Pancreatic Adenocarcinoma
Advanced Disease
Metastatic Disease

DRUG: 18F-Fluoroazomycin arabinoside

Faza-Maestro

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2014-05-28	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2018-02-14
First Submitted that Met QC Criteria 2015-07-13	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2018-02-19
First Posted (ACTUAL) 2015-07-14	Results First Posted N/A	Last Verified 2018-02

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Diagnostic

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: FAZA PET-CT scan FAZA PET-CT imaging within 14 days of treatment from the EMR200592-001 study. FAZA PET-CT imaging about 5 weeks after start of treatment from the EMR200592-001 study.	DRUG: 18F-Fluoroazomycin arabinoside

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: FAZA PET-CT scan

FAZA PET-CT imaging within 14 days of treatment from the EMR200592-001 study. FAZA PET-CT imaging about 5 weeks after start of treatment from the EMR200592-001 study.

DRUG: 18F-Fluoroazomycin arabinoside

Primary Outcome Measures	Measure Description	Time Frame
Expected number of similar quality scans produced compared to actual number of similar quality scans produced using the same method is less than 15%.		2 years
Number of enrolled patients that complete all required scans compared to total number of patients enrolled in the study is at least 70%.		2 years
Range of tumor hypoxia in patients with pancreatic cancer that had not received prior treatment.		2 years

Secondary Outcome Measures	Measure Description	Time Frame
Compare the changes in tumor hypoxia before chemotherapy treatments and after chemotherapy treatments.		2 years
Compare the changes in tumor hypoxia with response to chemotherapy treatments.		2 years
Evaluate how FAZA is taken in by different tumor types within individual patients.		2 years

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Have consented to participating on the first-line Gemcitabine + TH-302/placebo (study number EMR200592-001) study
Age 18 years or older
Cytologic/histologic diagnosis of pancreatic adenocarcinoma
Advanced stage pancreatic cancer: locally advanced or metastatic.
No prior chemotherapy for advanced/metastatic disease. Adjuvant chemotherapy allowed if completed > 6mths from study entry. Prior radio-sensitizing doses of 5-FU or gemcitabine also allowed.
ECOG performance status 1 or less
Adequate end organ and marrow function
Measureable or non-measureable disease by RECIST 1.1
Female patients of child-bearing potential must have a negative serum pregnancy test (BhCG) and must agree to abstinence or use adequate contraception for the duration of the study
Disease-free period of more than 5 years from prior malignancies other than pancreas (except curatively treated basal cell carcinoma, squamous cell carcinoma of the skin, or carcinoma in situ of the cervix and ductal carcinoma in situ (DCIS) breast disease).
Ability to provide written informed consent
Must be able to lie flat comfortably for 30 to 60 min to complete imaging study

Inability to lie supine for 30 to 60 minutes
Concurrent second primary
Life expectancy of less than 12 weeks
On treatment with disulfiram (antabuse) due to [18F]FAZA injection containing up to 10% (v/v) ethanol in PBS (phosphate-buffered saline)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Merck Frosst Canada Ltd.

Investigators

PRINCIPAL_INVESTIGATOR: Neesha Dhani, M.D., Princess Margaret Cancer Centre

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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