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An Imaging Pilot Study of 18F-fluoro-3'-Deoxy-3'-L-fluorothymidine (18F-FLT) in Patients With Locally Advanced or Metastatic Pancreatic Cancer Who Will be Treated With Gemcitabine

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by AHS Cancer Control Alberta
Sponsor:
Information provided by (Responsible Party):
AHS Cancer Control Alberta
ClinicalTrials.gov Identifier:
NCT00414570
First received: December 19, 2006
Last updated: February 4, 2014
Last verified: February 2014
  Purpose

The objective of this pilot study are (i) to compare response to chemotherapy, time to disease progression and overall survival in patients with pancreatic cancer who will be treated with gemcitabine who demonstrate 18F-FLT uptake to those patients who do not demonstrate 18F-FLT uptake; (ii) to correlate 18F-FLT uptake with hENT1 expression with biopsy samples where available; (iii)to determine the presence or absence of uptake, the relative uptake score (RUS) and tumor to background ratios of 18F-FLT in patients with known carcinoma of the pancreas and assess this uptake in relation to time to disease progression; and (iv) to demonstrate the safety of 18F-FLT manufactured at the Edmonton PET Centre.


Condition Intervention
Pancreatic Cancer
Procedure: Positron-Emission Tomography (PET) 18F-FLT

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: An Imaging Pilot Study of 18F-fluoro-3'-Deoxy-3'-L-fluorothymidine (18F-FLT) in Patients With Locally Advanced or Metastatic Pancreatic Cancer Who Will be Treated With Gemcitabine

Resource links provided by NLM:


Further study details as provided by AHS Cancer Control Alberta:

Primary Outcome Measures:
  • compare response to chemotherapy, time to disease progression and overall survival in pancreatic cancer patients treated with gemcitabine who demonstrate 18F-FLT uptake to those patients who do not demonstrate 18F-FLT uptake [ Time Frame: 5 Years ]
  • correlate 18F-FLT uptake with hENT1 expression with biopsy samples where available [ Time Frame: 5 Years ]

Secondary Outcome Measures:
  • determine the presence or absence of uptake, the relative uptake score (RUS) and tumor background ratios of 18F-FLT in patients with known carcinoma of the pancreas and assess this uptake in relation to time of disease progression [ Time Frame: 5 Years ]
  • to demonstrate the safety of 18F-FLT manufactured at the Edmonton PET Centre [ Time Frame: 5 Years ]

Estimated Enrollment: 30
Study Start Date: November 2006
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • male or female ≥ 18 years of age. If female of child bearing potential and outside of the window of 10 days since the first day of the last menstrual period, a negative pregnancy test
  • patients with known locally advanced or metastatic carcinoma of the pancreas
  • planned gemcitabine treatment
  • calculated creatinine clearance >50ml/min (calculated by Crockcraft and Gault equation)
  • able and willing to follow instructions and comply with the protocol
  • provide written consent prior to participation in this study
  • Karnofsky Performance Scale Score 60-100

Exclusion Criteria:

  • Bilirubin ≥200 umol/L
  • AST or ALT ≥5 times the upper limits of normal
  • Serious medical conditions which may prevent a patient from tolerating experimental chemotherapy such as: congestive heart failure, unstable angina, unstable ventricular arrhythmia, uncontrolled psychiatric conditions, serious infections, uncontrolled diabetes
  • uncontrolled brain metastasis. Patients who have stable brain metastasis treated with radiation or surgery who are symptomatic and a stable dose of dexamethasone are eligible
  • nursing females
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00414570

Contacts
Contact: Sandy McEwan, MD 780-432-8524 sandymce@cancerboard.ab.ca

Locations
Canada, Alberta
Cross Cancer Institute Recruiting
Edmonton, Alberta, Canada, T6G 1X2
Contact    780-432-8524      
Principal Investigator: Sandy McEwan, MD         
Sponsors and Collaborators
AHS Cancer Control Alberta
Investigators
Principal Investigator: Sandy McEwan, MD AHS Cancer Control Alberta
  More Information

No publications provided

Responsible Party: AHS Cancer Control Alberta
ClinicalTrials.gov Identifier: NCT00414570     History of Changes
Other Study ID Numbers: SP-14-0054 / 23061
Study First Received: December 19, 2006
Last Updated: February 4, 2014
Health Authority: Canada: Health Canada

Keywords provided by AHS Cancer Control Alberta:
Positron Emission Tomography (PET)
3'-deoxy-3'(18F)fluorothymidine ([18F]FLT)

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Neoplasms
Neoplasms by Site
Pancreatic Diseases
Gemcitabine
Anti-Infective Agents
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antiviral Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014