Status:

TERMINATED

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

Lead Sponsor:

AHS Cancer Control Alberta

Collaborating Sponsors:

Cross Cancer Institute

Conditions:

Pancreatic Cancer

Eligibility:

All Genders

18+ years

Phase:

EARLY_PHASE1

Brief Summary

The objectives 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 gemcitabin...

Detailed Description

The proposed clinical trial will be an imaging, open label, non-randomized, single site pilot study in patients with locally advanced or metastatic pancreatic carcinoma who will be treated with gemcit...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

November 1 2007

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

February 6 2019

Estimated Enrollment :

11 Patients enrolled

Trial Details

Trial ID

NCT00414570

Start Date

November 1 2007

End Date

February 6 2019

Last Update

August 28 2019

Active Locations (1)

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1

Cross Cancer Institute

Edmonton, Alberta, Canada, T6G 1Z2