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

• Status: Terminated
• Trial end date: 2019-02-06
• Target enrollment: 0
• Participant gender: All

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 gemcitabine (or other nucleoside analogs) who demonstrate [18]F-FLT uptake to those patients who do not demonstrate [18]F-FLT uptake; (ii) to correlate [18]F-FLT uptake with hENT1 expression in biopsy samples where available; (iii)to determine the presence or absence of uptake, the relative uptake score (RUS), standardized uptake value (SUV), and tumor to background ratios (T/B) of [18]F-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 [18]F-FLT.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AHS Cancer Control Alberta
• Collaborator: Cross Cancer Institute
• Treatments: Alovudine

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