CapTemY90 for Grade 2 NET Liver Metastases (CapTemY90)

December 1, 2023 updated by: Abramson Cancer Center at Penn Medicine

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Terminated
        • Carti Cancer Center
    • New York
      • Buffalo, New York, United States, 14203
        • Recruiting
        • Roswell Park Comprehensive Cancer Center
        • Contact:
        • Principal Investigator:
          • Renuka Iyer, MD
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19103

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Oral CapTem + Y90 Radioembolization

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.
Drug: Capecitabine Oral Product
Capecitabine 750 mg/m2 twice daily orally for 14 days
Other Names:
  • Xeloda
Drug: Temozolomide Oral Product
temozolomide 200 mg/m2 orally on Days 10-14, with 14 days between cycles
Other Names:
  • Temodar
Combination product: transarterial radioembolization
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.
Other Names:
  • TARE, y90

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intra-hepatic progression-free survival
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.
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.
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 Measures

Outcome Measure
Measure Description
Time Frame
Overall Progression free survival
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
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
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
Intra-hepatic tumor responses by RECIST
Time Frame: 2 years. from time of initiation of study therapy until subject comes off of study, or study closes
Intra-hepatic tumor responses will be evaluated by RECIST.
2 years. from time of initiation of study therapy until subject comes off of study, or study closes
Intra-hepatic tumor responses by EASL
Time Frame: 2 years. from time of initiation of study therapy until subject comes off of study, or study closes
Intra-hepatic tumor responses will be evaluated by EASL criteria.
2 years. from time of initiation of study therapy until subject comes off of study, or study closes
extra-hepatic tumor responses
Time Frame: 2 years. from time of initiation of study therapy until subject comes off of study, or study closes
extra-hepatic tumor responses will be evaluated by RECIST.
2 years. from time of initiation of study therapy until subject comes off of study, or study closes
Number of participants with systemic toxicities
Time Frame: From period of enrollment to 24 months after last treatment
Systemic toxicities will be individually assessed by NCI CTCAE Version 4.
From period of enrollment to 24 months after last treatment
Number of participants with hepatic toxicities
Time Frame: From period of enrollment to 24 months after last treatment
Hepatic toxicities will be individually assessed by NCI CTCAE Version 4.
From period of enrollment to 24 months after last treatment
Change in CgA over time
Time Frame: Tumor markers will be assessed at baseline and then every 3 months for 24 months.
The primary marker is CgA. Additional cancer site-specific (i.e., gastrinoma) markers may also be assayed.
Tumor markers will be assessed at baseline and then every 3 months for 24 months.
Quality of Life by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire for Neuroendocrine tumor
Time Frame: Quality of life will be measured at baseline and then every 3 months for 24 months .
Quality of Life will be measure by a validated NET-specific instrument, EORTC. Scale is 0-100, higher scores indicate worse symptoms/functioning
Quality of life will be measured at baseline and then every 3 months for 24 months .

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abramson Cancer Center at Penn Medicine

Collaborators

Roswell Park Cancer Institute
CARTI

Investigators

  • Principal Investigator: Michael Soulen, University of Pennsylvania

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 7, 2021

Primary Completion (Estimated)

May 1, 2025

Study Completion (Estimated)

May 1, 2026

Study Registration Dates

First Submitted

March 30, 2020

First Submitted That Met QC Criteria

April 7, 2020

First Posted (Actual)

April 8, 2020

Study Record Updates

Last Update Posted (Actual)

December 5, 2023

Last Update Submitted That Met QC Criteria

December 1, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 833304

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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