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

Pancreatic Adenocarcinoma Clinical Trial

Official title:

An Exploratory Study of Hypoxia Imaging Using 18F-FAZA-PET in Advanced Pancreatic Cancer Patients Being Treated With Gemcitabine + TH-302/Placebo (MAESTRO: EMR200592-001)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02496832
• Other study ID #: Faza-Maestro
• Status: Withdrawn
• Phase: N/A
• First received: May 28, 2014
• Last updated: February 14, 2018
• Start date: November 2014
• Est. completion date: November 2014

Study information

• Verified date: February 2018
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)

Related Conditions & MeSH terms

• Adenocarcinoma
• Advanced Disease
• Hypoxia
• Metastatic Disease
• Neoplasm Metastasis
• Pancreatic Adenocarcinoma
• Pancreatic Neoplasms

Intervention

Drug:
• 18F-Fluoroazomycin arabinoside

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University Health Network, Toronto	Merck Frosst Canada Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Range of tumor hypoxia in patients with pancreatic cancer that had not received prior treatment.		2 years
Secondary	Compare the changes in tumor hypoxia before chemotherapy treatments and after chemotherapy treatments.		2 years
Secondary	Compare the changes in tumor hypoxia with response to chemotherapy treatments.		2 years
Secondary	Evaluate how FAZA is taken in by different tumor types within individual patients.		2 years