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Trial record 44 of 1297 for:    survival | Neuroendocrine Tumors

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

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.

Condition or disease Intervention/treatment Phase
Neuroendocrine Tumors Radiation: [177Lu] DOTA-TATE Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 39 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of Peptide Receptor Radionuclide Therapy for Metastatic Inoperable Neuroendocrine Tumors Using 177-Lu-DOTA 0, Tyr 3 Octreotate
Study Start Date : November 2013
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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

  3. survival rate [ Time Frame: 2 years ]
    describe the 2-year survival rate of patients treated with 177Lu- DOTATATE

  4. 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.



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02125474


Contacts
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Contact: Diana I Cuellar, BSc 3341111 ext 5701 dcuellar@cancer.gov.co

Locations
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Colombia
Instituto Nacional de Cancerología Recruiting
Bogota, Cundinamarca, Colombia, 00000
Contact: Yeinnyer C Muleth, BSc    4320160 ext 5949    ymuleth@cancer.gov.co   
Principal Investigator: Carmen A De los Reyes, Md         
Sub-Investigator: Augusto E. Llamas, Md         
Sub-Investigator: Alejandro Martí, Md         
Sub-Investigator: Luis F Fierro, Md         
Sub-Investigator: Leonardo J Rojas, Md         
Sub-Investigator: Carlos E Granados, Md         
Sponsors and Collaborators
Instituto Nacional de Cancerologia, Columbia
Investigators
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Principal Investigator: Carmen A De los Reyes, Md Instituto Nacional de Cancerología

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Responsible Party: Instituto Nacional de Cancerologia, Columbia
ClinicalTrials.gov Identifier: NCT02125474     History of Changes
Other Study ID Numbers: C41030610-041
First Posted: April 29, 2014    Key Record Dates
Last Update Posted: October 10, 2016
Last Verified: May 2014

Keywords provided by Instituto Nacional de Cancerologia, Columbia:
Neuroendocrine Tumors
Lutetium
Treatment Outcome

Additional relevant MeSH terms:
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Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue