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

Primary Purpose

Pancreatic Adenocarcinoma, Advanced Disease, Metastatic Disease

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
18F-Fluoroazomycin arabinoside
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Pancreatic Adenocarcinoma focused on measuring Hypoxia, 18F-FAZA, 18F-Fluoroazomycin arabinoside, Positron emission tomography, PET, Participating in study EMR200592-001

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    FAZA PET-CT scan

    Arm Description

    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.

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Compare the changes in tumor hypoxia before chemotherapy treatments and after chemotherapy treatments.
    Compare the changes in tumor hypoxia with response to chemotherapy treatments.
    Evaluate how FAZA is taken in by different tumor types within individual patients.

    Full Information

    First Posted
    May 28, 2014
    Last Updated
    February 14, 2018
    Sponsor
    University Health Network, Toronto
    Collaborators
    Merck Frosst Canada Ltd.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02496832
    Brief Title
    A Study of Hypoxia Imaging in Advanced Pancreatic Cancer Patients Being Treated With Gemcitabine and TH-302 or TH-302 Placebo
    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)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2018
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Study was never initiated
    Study Start Date
    November 2014 (Actual)
    Primary Completion Date
    November 2014 (Actual)
    Study Completion Date
    November 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University Health Network, Toronto
    Collaborators
    Merck Frosst Canada Ltd.

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pancreatic Adenocarcinoma, Advanced Disease, Metastatic Disease
    Keywords
    Hypoxia, 18F-FAZA, 18F-Fluoroazomycin arabinoside, Positron emission tomography, PET, Participating in study EMR200592-001

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    FAZA PET-CT scan
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    18F-Fluoroazomycin arabinoside
    Other Intervention Name(s)
    18F-FAZA, [18F] FAZA
    Primary Outcome Measure Information:
    Title
    Expected number of similar quality scans produced compared to actual number of similar quality scans produced using the same method is less than 15%.
    Time Frame
    2 years
    Title
    Number of enrolled patients that complete all required scans compared to total number of patients enrolled in the study is at least 70%.
    Time Frame
    2 years
    Title
    Range of tumor hypoxia in patients with pancreatic cancer that had not received prior treatment.
    Time Frame
    2 years
    Secondary Outcome Measure Information:
    Title
    Compare the changes in tumor hypoxia before chemotherapy treatments and after chemotherapy treatments.
    Time Frame
    2 years
    Title
    Compare the changes in tumor hypoxia with response to chemotherapy treatments.
    Time Frame
    2 years
    Title
    Evaluate how FAZA is taken in by different tumor types within individual patients.
    Time Frame
    2 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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)
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Neesha Dhani, M.D.
    Organizational Affiliation
    Princess Margaret Cancer Centre
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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