Ignite Creation Date:
2024-05-06 @ 2:02 PM
Last Modification Date:
2024-10-26 @ 1:24 PM
Study NCT ID:
NCT04194125
Status:
UNKNOWN
Last Update Posted:
2020-11-04
First Post:
2019-12-07
Brief Title:
Personalized CAPTEM Radiopeptide Therapy of Advanced Non-resectable Neuroendocrine Cancer
Sponsor:
University of Warmia and Mazury
Organization:
University of Warmia and Mazury
Study Overview
Official Title:
Clinical Study of Radiopeptide 177Lu-DOTATOC in Combination With Capecitabine and Temozolomide in Advanced Non-resectable and Progressive Neuroendocrine Tumors With Somatostatin Receptor Overexpression
Status:
UNKNOWN
Status Verified Date:
2020-11
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a non-randomized phase II open label study The purpose of this study is to estimate Progression Free Survival PFS after treatment with Peptide Receptor Radionuclide Therapy PRRT 177Lu-DOTATOC standard dose up to 4x74GBq 177Lu DOTATOC in combination with capecitabine CAP and temozolomide TEM - CAPTEM
Patients with advanced non-resectable andor progressive gastro-entero-pancreatic neuroendocrine tumors GEP-NET G1 G2 in selected cases with high proliferation index Ki-67 20 usually below 55 NETG3 with overexpression of somatostatin receptor SSTR positive will be enrolled in the study
Patients with advanced non-resectable andor progressive gastro-entero-pancreatic neuroendocrine tumors GEP-NET G1 G2 in selected cases with high proliferation index Ki-67 20 usually below 55 NETG3 with overexpression of somatostatin receptor SSTR positive will be enrolled in the study
Detailed Description:
This is a non-randomized phase II open label study
The purpose of this study is to
estimate Progression Free Survival PFS after treatment with Peptide Receptor Radionuclide Therapy PRRT 177Lu-DOTATOC standard dose up to 4x74GBq 177Lu DOTATOC in combination with capecitabine CAP and temozolomide TEM - CAPTEM
Patients with advanced non-resectable andor progressive gastro-entero-pancreatic neuroendocrine tumors GEP-NET according to WHO 2017 classification histological grade G1 G2 in selected cases patients with high proliferation index Ki-67 20 usually below 55 NETG3 - pancreatic midgut neuroendocrine tumors and carcinoma of unknown primary CUP All with overexpression of somatostatin receptor SSTR positive based on somatostin receptor scintigraphy SRS will be enrolled in this study
evaluate the safety and tolerability of combination therapy using 177Lu-DOTATOC and CAPTEM
evaluate the health related quality of life QoL as measured by the European Organization for Research and Treatment of Cancer EORTC QLQ-GINET21 questionnaire
evaluate internal dosimetry in a subset up to 20 patients but at least 10 patients
explore the correlation of clinical efficacy outcomes with Somatostatin Receptor Scintigraphy SRS using 99mTc HYNICTOC Tektordyt tumour uptake score
explore the correlation of clinical efficacy outcomes with the levels of some specific and non-specific biomarkers and gene transcripts analysis
compare the Time to Tumour Progression TTP
The schedule of treatment will include 4 courses capecitabine CAP which will be administrated for 14 days with 8-week breaks combined at 10th day with 177Lu-DOTATOC PRRT - Peptide Receptor Radionuclide Therapy in doses from 555GBq up to 74 GBq administered iv up to four times in every patient during whole therapy
In selected patients in those with only liver involvement or dominant liver bulky disease third and fourth administration of PRRT will be used intra-arterial administration ia via hepatic artery The administered dose will be from 285 GBq up to 37GBq up to two times per whole therapy followed in each case of iv or ia PRRT by Temozolomide TEM po administration which will be given during 10-14th days in each therapy sessions
Doses of PRRT could be modified due to clinical stage and laboratory parameters Treatment will be discontinued in the case of a cumulative dose 296 GBq corresponding to the radiation dose on the bone marrow below 2 Gy and cumulative dose on kidney below 23 Gy In case of radiation dose on kidney above 23 Gy treatment will be interrupted
The purpose of this study is to
estimate Progression Free Survival PFS after treatment with Peptide Receptor Radionuclide Therapy PRRT 177Lu-DOTATOC standard dose up to 4x74GBq 177Lu DOTATOC in combination with capecitabine CAP and temozolomide TEM - CAPTEM
Patients with advanced non-resectable andor progressive gastro-entero-pancreatic neuroendocrine tumors GEP-NET according to WHO 2017 classification histological grade G1 G2 in selected cases patients with high proliferation index Ki-67 20 usually below 55 NETG3 - pancreatic midgut neuroendocrine tumors and carcinoma of unknown primary CUP All with overexpression of somatostatin receptor SSTR positive based on somatostin receptor scintigraphy SRS will be enrolled in this study
evaluate the safety and tolerability of combination therapy using 177Lu-DOTATOC and CAPTEM
evaluate the health related quality of life QoL as measured by the European Organization for Research and Treatment of Cancer EORTC QLQ-GINET21 questionnaire
evaluate internal dosimetry in a subset up to 20 patients but at least 10 patients
explore the correlation of clinical efficacy outcomes with Somatostatin Receptor Scintigraphy SRS using 99mTc HYNICTOC Tektordyt tumour uptake score
explore the correlation of clinical efficacy outcomes with the levels of some specific and non-specific biomarkers and gene transcripts analysis
compare the Time to Tumour Progression TTP
The schedule of treatment will include 4 courses capecitabine CAP which will be administrated for 14 days with 8-week breaks combined at 10th day with 177Lu-DOTATOC PRRT - Peptide Receptor Radionuclide Therapy in doses from 555GBq up to 74 GBq administered iv up to four times in every patient during whole therapy
In selected patients in those with only liver involvement or dominant liver bulky disease third and fourth administration of PRRT will be used intra-arterial administration ia via hepatic artery The administered dose will be from 285 GBq up to 37GBq up to two times per whole therapy followed in each case of iv or ia PRRT by Temozolomide TEM po administration which will be given during 10-14th days in each therapy sessions
Doses of PRRT could be modified due to clinical stage and laboratory parameters Treatment will be discontinued in the case of a cumulative dose 296 GBq corresponding to the radiation dose on the bone marrow below 2 Gy and cumulative dose on kidney below 23 Gy In case of radiation dose on kidney above 23 Gy treatment will be interrupted
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None