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

NCT02125474 | Completed DMC

• 1 other identifier: C41030610-041
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Neuroendocrine Tumors

Keywords

Neuroendocrine Tumors; Lutetium; Treatment Outcome

Outcome Measures

Primary Outcomes (1)

• Response to treatment

  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.

  3 years

Secondary Outcomes (4)

• Efficacy defined by reduction in size tumoral

  3 years

• Side effects defined by clinical follow up

  5 years

• survival rate

  2 years

• Quality of life

  3 years

Study Arms (1)

[177Lu] DOTA-TATE

EXPERIMENTAL

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

Interventions

[177Lu] DOTA-TATE RADIATION

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.

[177Lu] DOTA-TATE

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Instituto Nacional de Cancerologia, Columbia: lead

Study Sites (1)

Instituto Nacional de Cancerología

Bogota, Cundinamarca, 00000, Colombia

Location

MeSH Terms

Conditions

Neuroendocrine Tumors

Interventions

Lutetium-177; copper dotatate CU-64

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue

Study Officials

• Carmen A De los Reyes, Md

  Instituto Nacional de Cancerologia de Mexico

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2014
• First Posted: April 29, 2014
• Study Start: November 1, 2013
• Primary Completion: October 1, 2019
• Study Completion: October 1, 2019
• Last Updated: November 14, 2019

Record last verified: 2014-05

Locations

CO (1)