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 - Full Text View

Sponsored by:	Alberta Cancer Board
Information provided by:	Alberta Cancer Board
ClinicalTrials.gov Identifier:	NCT00414570

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

MedlinePlus related topics: Cancer Pancreatic Cancer

Drug Information available for: Gemcitabine hydrochloride Gemcitabine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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

Further study details as provided by Alberta Cancer Board:

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:	November 2012

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

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: Clinical Research Unit 780-989-8152 clinical_trials_cci@cancerboard.ab.ca
Principal Investigator: Sandy McEwan, MD

Sponsors and Collaborators

Alberta Cancer Board

Investigators

Principal Investigator:

Sandy McEwan, MD

Alberta Cancer Board

More Information

Study ID Numbers:	SP-14-0054
Study First Received:	December 19, 2006
Last Updated:	September 22, 2008
ClinicalTrials.gov Identifier:	NCT00414570
Health Authority:	Canada: Health Canada

Keywords provided by Alberta Cancer Board:

Positron Emission Tomography (PET)
3'-deoxy-3'(18F)fluorothymidine ([18F]FLT)

Study placed in the following topic categories:

Digestive System Diseases
Digestive System Neoplasms
Pancreatic Neoplasms
Endocrine System Diseases
Pancreatic Diseases

Gastrointestinal Neoplasms
Endocrinopathy
Gemcitabine
Endocrine Gland Neoplasms

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Enzyme Inhibitors

Antiviral Agents
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on January 16, 2009