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CapTemY90 for Grade 2 NET Liver Metastases (CapTemY90)

Primary Purpose

Neuroendocrine Tumor Grade 2, Neuroendocrine Tumors

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Capecitabine Oral Product
Temozolomide Oral Product
transarterial radioembolization
Sponsored by
Abramson Cancer Center at Penn Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neuroendocrine Tumor Grade 2

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with confirmed diagnosis of histologic grade 2 neuroendocrine tumor with unresectable liver metastases (primary tumor or other extrahepatic disease may be present)
  • Patients with at least one measurable liver metastases, with size > 1cm (RECIST criteria)
  • Patients with liver dominant disease defined as ≥50% tumor body burden confined to the liver
  • Liver tumor burden does not exceed 50% of the liver volume
  • Patent main portal vein
  • At least 4 weeks since last administration of last chemotherapy and /or radiotherapy
  • Age >18 years.
  • Life expectancy of greater than 6 months.
  • ECOG performance status 0-2.
  • Adequate liver function as measured by: Total bilirubin ≤ 2.0mg/dl, ALT, AST ≤5 times ULN, albumin ≥2.5g/dl.
  • Patients must have adequate organ and marrow function as defined below:
  • platelets >100,000/mcL (may be corrected by transfusion)
  • serum creatinine < 2.0 mg/dl
  • INR <1.6, (may be corrected by transfusion)
  • Ability to understand and the willingness to sign a written informed consent document.
  • Women of child bearing potential and fertile men are required to use effective contraception (negative urine or serum βHCG for women of child-bearing age)

Exclusion Criteria:

  • Contraindications to capecitibine or temozolomide
  • Contraindicated for both contrast-enhanced MRI and CT
  • Patients previously treated with transarterial embolization (with or without chemotherapy) or with radioembolization (Y-90 microspheres)
  • Contraindication for radioembolization procedures:
  • excessive hepatopulmonary shunt as determined by the investigator
  • inability to deliver Y90 microspheres without risk of non-target embolization of extra-hepatic structures
  • Subjects consenting to the trial who fail their simulation angiography will be removed from the study and replaced.
  • Patients may not be receiving any other investigational agents.
  • Absolute contraindication to intravenous iodinated contrast (Hx of significant previous contrast reaction, not mitigated by appropriate pre-medication).
  • Choledochoenteric anastomosis, transpapillary stent or sphincterotomy of duodenal papilla;
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Pregnant and lactating women are ineligible

Sites / Locations

  • CARTI Cancer CenterRecruiting
  • Roswell Park Comprehensive Cancer CenterRecruiting
  • University of PennsylvaniaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Oral CapTem + Y90 Radioembolization

Arm Description

Capecitabine 750 mg/m2 twice daily orally for 14 days and temozolomide 200 mg/m2 orally on Days 10-14, with 14 days between cycles, to be continued until 1) disease progression or 2) intolerable toxicities. Trans-arterial radioembolization (TARE) on Day 7 of cycle 2 and, if needed for the other lobe, Day 7 of either cycle 3 or 4.

Outcomes

Primary Outcome Measures

Intra-hepatic progression-free survival
Intra-hepatic progression-free survival by RECIST 1.0 is defined as the time from initiation of study therapy until first documented intra-hepatic disease progression, death due to any cause or last scan date that documented intra-hepatic progression-free status.

Secondary Outcome Measures

Overall Progression free survival
Overall progression-free survival is defined as the time from initiation of study therapy until first documented intra- or extra-hepatic disease progression, death due to any cause or last scan date that documented progression-free status
Intra-hepatic tumor responses by RECIST
Intra-hepatic tumor responses will be evaluated by RECIST.
Intra-hepatic tumor responses by EASL
Intra-hepatic tumor responses will be evaluated by EASL criteria.
extra-hepatic tumor responses
extra-hepatic tumor responses will be evaluated by RECIST.
Number of participants with systemic toxicities
Systemic toxicities will be individually assessed by NCI CTCAE Version 4.
Number of participants with hepatic toxicities
Hepatic toxicities will be individually assessed by NCI CTCAE Version 4.
Change in CgA over time
The primary marker is CgA. Additional cancer site-specific (i.e., gastrinoma) markers may also be assayed.
Quality of Life by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire for Neuroendocrine tumor
Quality of Life will be measure by a validated NET-specific instrument, EORTC. Scale is 0-100, higher scores indicate worse symptoms/functioning

Full Information

First Posted
March 30, 2020
Last Updated
September 25, 2023
Sponsor
Abramson Cancer Center at Penn Medicine
Collaborators
Roswell Park Cancer Institute, CARTI
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1. Study Identification

Unique Protocol Identification Number
NCT04339036
Brief Title
CapTemY90 for Grade 2 NET Liver Metastases
Acronym
CapTemY90
Official Title
UPCC 04219 Phase 2 Study of Capecitabine-Temozolomide(CapTem) With Yttrium-90 Radioembolization in the Treatment of Patients With Unresectable Metastatic Grade 2 Neuroendocrine Tumors
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 7, 2021 (Actual)
Primary Completion Date
May 1, 2025 (Anticipated)
Study Completion Date
May 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abramson Cancer Center at Penn Medicine
Collaborators
Roswell Park Cancer Institute, CARTI

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a Phase 2 evaluation of hepatic-progression free survival among patients with Grade 2 liver-dominant NET metastases undergoing combination therapy with CapTem and Y90 radioembolization.The hypothesis is to confirm safety and to assess if disease control is improved relative to expectation from either therapy alone.
Detailed Description
Patients with liver-dominant Grade 2 NET metastases from any primary will start CapTem and undergo simulation angiography for radioembolization planning during the first cycle. If they tolerate CapTem and are not excluded from radioembolization, then TARE will be performed on Day 7 of Cycle 2, with additional TARE of Day 7 of cycle 3 or 4 as needed to treat the entire tumor burden. Patients will remain on CapTem until progression or intolerance. Primary outcome measure is hepatic progression-free survival.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuroendocrine Tumor Grade 2, Neuroendocrine Tumors

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Oral CapTem + Y90 Radioembolization
Arm Type
Experimental
Arm Description
Capecitabine 750 mg/m2 twice daily orally for 14 days and temozolomide 200 mg/m2 orally on Days 10-14, with 14 days between cycles, to be continued until 1) disease progression or 2) intolerable toxicities. Trans-arterial radioembolization (TARE) on Day 7 of cycle 2 and, if needed for the other lobe, Day 7 of either cycle 3 or 4.
Intervention Type
Drug
Intervention Name(s)
Capecitabine Oral Product
Other Intervention Name(s)
Xeloda
Intervention Description
Capecitabine 750 mg/m2 twice daily orally for 14 days
Intervention Type
Drug
Intervention Name(s)
Temozolomide Oral Product
Other Intervention Name(s)
Temodar
Intervention Description
temozolomide 200 mg/m2 orally on Days 10-14, with 14 days between cycles
Intervention Type
Combination Product
Intervention Name(s)
transarterial radioembolization
Other Intervention Name(s)
TARE, y90
Intervention Description
Trans-arterial radioembolization (TARE) on Day 7 of cycle 2 and, if needed for the other lobe, Day 7 of either cycle 3 or 4.
Primary Outcome Measure Information:
Title
Intra-hepatic progression-free survival
Description
Intra-hepatic progression-free survival by RECIST 1.0 is defined as the time from initiation of study therapy until first documented intra-hepatic disease progression, death due to any cause or last scan date that documented intra-hepatic progression-free status.
Time Frame
2 years. Time from initiation of study therapy until first documented intra-hepatic disease progression, death due to any cause or last scan date that documented intra-hepatic progression-free status.
Secondary Outcome Measure Information:
Title
Overall Progression free survival
Description
Overall progression-free survival is defined as the time from initiation of study therapy until first documented intra- or extra-hepatic disease progression, death due to any cause or last scan date that documented progression-free status
Time Frame
2 years. time from initiation of study therapy until first documented intra- or extra-hepatic disease progression, death due to any cause or last scan date that documented progression-free status
Title
Intra-hepatic tumor responses by RECIST
Description
Intra-hepatic tumor responses will be evaluated by RECIST.
Time Frame
2 years. from time of initiation of study therapy until subject comes off of study, or study closes
Title
Intra-hepatic tumor responses by EASL
Description
Intra-hepatic tumor responses will be evaluated by EASL criteria.
Time Frame
2 years. from time of initiation of study therapy until subject comes off of study, or study closes
Title
extra-hepatic tumor responses
Description
extra-hepatic tumor responses will be evaluated by RECIST.
Time Frame
2 years. from time of initiation of study therapy until subject comes off of study, or study closes
Title
Number of participants with systemic toxicities
Description
Systemic toxicities will be individually assessed by NCI CTCAE Version 4.
Time Frame
From period of enrollment to 24 months after last treatment
Title
Number of participants with hepatic toxicities
Description
Hepatic toxicities will be individually assessed by NCI CTCAE Version 4.
Time Frame
From period of enrollment to 24 months after last treatment
Title
Change in CgA over time
Description
The primary marker is CgA. Additional cancer site-specific (i.e., gastrinoma) markers may also be assayed.
Time Frame
Tumor markers will be assessed at baseline and then every 3 months for 24 months.
Title
Quality of Life by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire for Neuroendocrine tumor
Description
Quality of Life will be measure by a validated NET-specific instrument, EORTC. Scale is 0-100, higher scores indicate worse symptoms/functioning
Time Frame
Quality of life will be measured at baseline and then every 3 months for 24 months .

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with confirmed diagnosis of histologic grade 2 neuroendocrine tumor with unresectable liver metastases (primary tumor or other extrahepatic disease may be present) Patients with at least one measurable liver metastases, with size > 1cm (RECIST criteria) Patients with liver dominant disease defined as ≥50% tumor body burden confined to the liver Liver tumor burden does not exceed 50% of the liver volume Patent main portal vein At least 4 weeks since last administration of last chemotherapy and /or radiotherapy Age >18 years. Life expectancy of greater than 6 months. ECOG performance status 0-2. Adequate liver function as measured by: Total bilirubin ≤ 2.0mg/dl, ALT, AST ≤5 times ULN, albumin ≥2.5g/dl. Patients must have adequate organ and marrow function as defined below: platelets >100,000/mcL (may be corrected by transfusion) serum creatinine < 2.0 mg/dl INR <1.6, (may be corrected by transfusion) Ability to understand and the willingness to sign a written informed consent document. Women of child bearing potential and fertile men are required to use effective contraception (negative urine or serum βHCG for women of child-bearing age) Exclusion Criteria: Contraindications to capecitibine or temozolomide Contraindicated for both contrast-enhanced MRI and CT Patients previously treated with transarterial embolization (with or without chemotherapy) or with radioembolization (Y-90 microspheres) Contraindication for radioembolization procedures: excessive hepatopulmonary shunt as determined by the investigator inability to deliver Y90 microspheres without risk of non-target embolization of extra-hepatic structures Subjects consenting to the trial who fail their simulation angiography will be removed from the study and replaced. Patients may not be receiving any other investigational agents. Absolute contraindication to intravenous iodinated contrast (Hx of significant previous contrast reaction, not mitigated by appropriate pre-medication). Choledochoenteric anastomosis, transpapillary stent or sphincterotomy of duodenal papilla; Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. Pregnant and lactating women are ineligible
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michael Soulen, MD
Phone
855-216-0098
Email
michael.soulen@pennmedicine.upenn.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Kathleen Thomas
Phone
215-746-0352
Email
kathleen.thomas@pennmedicine.upenn.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Soulen
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
CARTI Cancer Center
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Randi Mackey
Email
Randi.Mackey@CARTI.com
First Name & Middle Initial & Last Name & Degree
David Hays, MD
Facility Name
Roswell Park Comprehensive Cancer Center
City
Buffalo
State/Province
New York
ZIP/Postal Code
14203
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Deepon Paul Singh
Phone
800-767-9355
Email
mailto:askroswell@roswellpark.org
First Name & Middle Initial & Last Name & Degree
Renuka Iyer, MD
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19103
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abashai Woodard
Phone
215-746-7050
Email
abashai.woodard@pennmedicine.upenn.edu
First Name & Middle Initial & Last Name & Degree
Michael Soulen, MD

12. IPD Sharing Statement

Plan to Share IPD
No
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CapTemY90 for Grade 2 NET Liver Metastases

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