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Efficacy of 177-Lu-DOTA 0, Tyr 3 Octreotate

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ClinicalTrials.gov Identifier: NCT02125474
Recruitment Status : Recruiting
First Posted : April 29, 2014
Last Update Posted : October 10, 2016
Sponsor:
Information provided by (Responsible Party):
Instituto Nacional de Cancerologia, Columbia

Tracking Information
First Submitted Date  ICMJE April 22, 2014
First Posted Date  ICMJE April 29, 2014
Last Update Posted Date October 10, 2016
Study Start Date  ICMJE November 2013
Estimated Primary Completion Date October 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 25, 2014)
Response to treatment [ Time Frame: 3 years ]
Response to palliative treatment with 177Lu- DOTATATE in patients with metastatic progressive low-grade neuroendocrine tumors defined by control size tumor, response time to reduction minimal parcial and complete tumor.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02125474 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 25, 2014)
  • Efficacy defined by reduction in size tumoral [ Time Frame: 3 years ]
    Measure the efficacy of 177Lu- DOTATATE to treat patients with metastatic progressive low-grade neuroendocrine tumors using clinical and imaging criteria such as tumor size.
  • Side effects defined by clinical follow up [ Time Frame: 5 years ]
    Describe the side effects of the treatment with 177Lu- DOTATATE by clinical follow-up during and after therapy
  • survival rate [ Time Frame: 2 years ]
    describe the 2-year survival rate of patients treated with 177Lu- DOTATATE
  • Quality of life [ Time Frame: 3 years ]
    Assess the quality of life of patients with metastatic progressive low-grade neuroendocrine tumors treated with 177Lu- DOTATATE during treatment defined by pain reduction and tolerability.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of 177-Lu-DOTA 0, Tyr 3 Octreotate
Official Title  ICMJE Efficacy of Peptide Receptor Radionuclide Therapy for Metastatic Inoperable Neuroendocrine Tumors Using 177-Lu-DOTA 0, Tyr 3 Octreotate
Brief Summary Well-differentiated neuroendocrine tumors (WDNETs) are uncommon neoplasms with an increasing number of new cases reported in the annual statistics of the Instituto Nacional de Cancerología (INC). The majority are advanced-stage presentations with limited chances of a complete surgical resection of the primary tumor, a clinical scenario where medical treatment options are also limited. In view of the characteristically defined expression of peptide receptors in WDNETs, radioactive molecular probes to target specific cellular receptors have been designed using radioisotopes with short range of penetration in tissues. We have designed a one-arm phase II prospective sequential clinical trial to assess the therapeutic efficacy of 177-Lu-[DOTA 0, Tyr 3] octreotate (177-Lu- DOTATATE) applied intravenously in three separate doses to patients with inoperable progressive WDNET. Selected patients matching inclusion criteria will be enrolled at the INC's Section of Endocrinology. Tumor response, treatment safety (side effects) and survival will be appraised. Data from clinical, biochemical and imaging follow-up will be periodically registered during treatment and until two years after the last infusion of 177Lu- DOTATATE. This phase II trial is justified because despite the fact that many preclinical and clinical studies have showed the potential usefulness of this novel palliative approach to treat patients with advanced-stage WDNETs there is a paucity of vigorous results to establish its efficacy as first-line treatment.
Detailed Description The Investigators have designed a one-arm phase II prospective sequential clinical trial to assess the therapeutic efficacy of 177-Lu-[DOTA 0, Tyr 3] octreotate (177-Lu- DOTATATE) applied intravenously in three separate doses to patients with inoperable progressive WDNET.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Neuroendocrine Tumors
Intervention  ICMJE Radiation: [177Lu] DOTA-TATE
We have designed a one-arm phase II prospective sequential clinical trial to assess the therapeutic efficacy of 177-Lu-[DOTA 0, Tyr 3] octreotate (177-Lu- DOTATATE) applied intravenously in three separate doses to patients with inoperable progressive WDNET.
Study Arms  ICMJE Experimental: [177Lu] DOTA-TATE
We have designed a one-arm phase II prospective sequential clinical trial to assess the therapeutic efficacy of 177-Lu-[DOTA 0, Tyr 3] octreotate (177-Lu- DOTATATE) applied intravenously in three separate doses to patients with inoperable progressive WDNET.
Intervention: Radiation: [177Lu] DOTA-TATE
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 25, 2014)
39
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2019
Estimated Primary Completion Date October 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients with inoperable gastroenteropancreatic neuroendocrine tumors.
  • Histopathologic diagnosis confirmed at the Instituto Nacional de Cancerología.
  • Somatostatin receptor-positive tumors with at least one site of abnormal focal uptake > liver physiologic uptake (3+) observed in a 99mTc-HYNIC-TOC scintigraphy practiced less than 6 months before treatment with 177Lu- DOTATATE.
  • Karnofsky functional score > 60.
  • Life expectancy > 3 months.
  • Multiple inoperable metastatic sites.
  • Patient voluntarily willing to participate in the trial.
  • Hemoglobin (Hb) > 8.8 g/dl
  • Leucocytes (Leu) > 2 x 103/µl
  • Platelets (Plaq) > 80 x 103/µl
  • Total Bilirrubin (BT) ≤ 3 times the upper limit of normal range. Serum albumin > 3 g/dl and normal prothrombin time.
  • At least one measurable CT tumor lesion.
  • Non-lactating woman with negative pregnancy blood test.
  • Creatinine clearance > 40 ml/min and serum creatinine < 1.5 mg/dl and/or isotopic glomerular filtration rate > 50 ml/min.
  • Test results should predate treatment by at least: blood test results ≤ 4 weeks, liver blood tests < 1 month, renal function tests < 1 week, CT ≤ 4 months and 99mTc-HYNIC-TOC scintigraphy < 6 months.

Exclusion Criteria:

  • Patients previously treated with radionuclide therapy.
  • Patients treated with chemo- o radiotherapy within the past 6 months.
  • Patients unable to comply with clinical follow-up in both Nuclear Medicine and Endocrinology units.
  • Patients unwilling to participate in the trial or not providing written informed consent.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Diana I Cuellar, BSc 3341111 ext 5701 dcuellar@cancer.gov.co
Listed Location Countries  ICMJE Colombia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02125474
Other Study ID Numbers  ICMJE C41030610-041
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Instituto Nacional de Cancerologia, Columbia
Study Sponsor  ICMJE Instituto Nacional de Cancerologia, Columbia
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Carmen A De los Reyes, Md Instituto Nacional de Cancerología
PRS Account Instituto Nacional de Cancerologia, Columbia
Verification Date May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP