Review of Medical Records of Patients Who Have Been Treated With Lutetium at the Cross Cancer Institute Between January 2010 and July 31, 2012

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
AHS Cancer Control Alberta
ClinicalTrials.gov Identifier:
NCT01763554
First received: December 19, 2012
Last updated: February 27, 2014
Last verified: February 2014
  Purpose

Review of the medical files of 69 patients with neuroendocrine tumours who were treated at the CCI from January/10 - July/12 with Lutetium-177 DOTA-TATE under Health Canada's Special Access Programme (SAP). Efficacy, safety, and other relevant data will be collected.


Condition Intervention
Neuroendocrine Tumors, NET
Drug: Lu-177 DOTA-TATE

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Review of Medical Records of Patients Who Have Been Treated With Lutetium at the Cross Cancer Institute Between January 2010 and July 31, 2012

Resource links provided by NLM:


Further study details as provided by AHS Cancer Control Alberta:

Primary Outcome Measures:
  • Efficacy data on subjects with neuroendocrine tumours (NET) treated Lu-177 DOTA-TATE [ Time Frame: Retrospective data January 2010 - July 2012 ] [ Designated as safety issue: No ]
    Data (Radioisotope and CT/MRI images, blood assays and Quality of Life Questionnaires, pre and post treatment) will be collected to determine tumor response of subjects with NET after treatment with Lu-177 DOTA-TATE.


Secondary Outcome Measures:
  • Safety and other relevant information on subjects treated with Lu-177 DOTA-TATE [ Time Frame: Retrospective data January 2010 - July 2012 ] [ Designated as safety issue: No ]
    Safety data will include blood counts and chemistry, GFR and adverse events, pre and post treatment. Other data includes patient demographics.


Estimated Enrollment: 69
Study Start Date: October 2012
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Lu-177 DOTA-TATE
    Radiopharmaceutical solution for IV injection containing DOTA-TATE labeled with Lutetium-177. Standard dose is 5.5 GBq given as a single injection once every 8 to 12 weeks for 4 doses, followed by maintenance doses of 5.5 GBq every 6 months.
Detailed Description:

Neuroendocrine tumours comprise a spectrum of rare neoplasms. Data analysis will be conducted to obtain efficacy, safety, and other relevant data from each Lu-177 DOTA-TATE treatment.

  Eligibility

Ages Eligible for Study:   14 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Limited to those subjects with neuroendocrine tumors who received Lu-177 DOTA-TATE between January 2010 and July 2012 at the Cross Cancer Institute.

Criteria

Inclusion Criteria:

  • Male or female ≥ 14 - 90 years of age
  • Presence of histologically proven NET tumour(s)
  • Serum creatinine ≤ 150 µmol/L, and a measured GFR using plasma clearance of ≥50 mL/min
  • Haemoglobin concentration 5.5 mmol/L; WBC ≥ 2*109/L; platelets ≥ 100*109/L
  • Liver function tests (serum albumin, total bilirubin, ALT, AST and alkaline phosphatase) ≤ 3X the upper limit of normal

Exclusion Criteria:

  • Potential for surgery with curative intent
  • Surgery, radiation therapy, cytotoxic chemotherapy, embolization or other investigative therapy (interferons, mTOR inhibitors) within 12 weeks of enrollment
  • Known brain metastases unless these metastases have been treated and stabilized (confirmed by CT) for ≥ 6 months prior to enrollment
  • Uncontrolled congestive heart failure
  • Receiving concomitant medications which decrease renal function
  • Uncontrolled diabetes mellitus
  • Pregnancy
  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: NCT01763554

Locations
Canada, Alberta
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Sponsors and Collaborators
AHS Cancer Control Alberta
Investigators
Principal Investigator: Alexander McEwan, MD AHS Cancer Control Alberta
  More Information

No publications provided

Responsible Party: AHS Cancer Control Alberta
ClinicalTrials.gov Identifier: NCT01763554     History of Changes
Other Study ID Numbers: REV-LUT-001
Study First Received: December 19, 2012
Last Updated: February 27, 2014
Health Authority: Canada: Health Canada

Keywords provided by AHS Cancer Control Alberta:
Lu-177
Lutetium-177
DOTA-TATE
Neuroendocrine tumors
radiopharmaceutical

Additional relevant MeSH terms:
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Radiopharmaceuticals
Diagnostic Uses of Chemicals
Pharmacologic Actions
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 20, 2014