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Study of Capecitabine-Temozolomide(CapTem) With Yttrium-90 in Patients With Unresectable Metastatic Grade 2 Neuroendocrine Tumors

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ClinicalTrials.gov Identifier: NCT04339036
Recruitment Status : Recruiting
First Posted : April 8, 2020
Last Update Posted : January 19, 2022
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania

Study Description
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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.

Condition or disease Intervention/treatment Phase
Neuroendocrine Tumor Grade 2 Neuroendocrine Tumors Drug: Capecitabine Oral Product Drug: Temozolomide Oral Product Combination Product: transarterial radioembolization Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : January 21, 2022
Estimated Primary Completion Date : May 1, 2025
Estimated Study Completion Date : May 1, 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: Xeloda

Drug: Temozolomide Oral Product
temozolomide 200 mg/m2 orally on Days 10-14, with 14 days between cycles
Other Name: 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 Name: TARE, y90


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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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): NCT04339036


Contacts
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Contact: Michael Soulen, MD 855-216-0098 michael.soulen@pennmedicine.upenn.edu
Contact: Kathleen Thomas 215-746-0352 kathleen.thomas@pennmedicine.upenn.edu

Locations
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United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19103
Contact: Abashai Woodard    215-746-7050    abashai.woodard@pennmedicine.upenn.edu   
Contact: Aamir Razak       Aamir.Razak@pennmedicine.upenn.edu   
Principal Investigator: Michael Soulen, MD         
Sponsors and Collaborators
University of Pennsylvania
Investigators
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Principal Investigator: Michael Soulen University of Pennsylvania
More Information
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Publications:
Talamonti MS, Stuart K, Yao JC. Neuroendocrine tumors of the gastrointestinal tract: how aggressive should we be? In: Perry M, ed. American Society of Clinical Oncology 2004 Education Book. Alexandria: American Society of Clinical Oncology, 2004;206-215.
Kunz PL, et al. A randomized phase II study of temozolomide or temozolomide and capecitabine in patients with advanced pancreatic neuroendocrine tumors: A trial of the ECOG-ACRIN cancer research Group (E2211). ASCO 2018.

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Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT04339036    
Obsolete Identifiers: NCT04789109
Other Study ID Numbers: 833304
First Posted: April 8, 2020    Key Record Dates
Last Update Posted: January 19, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Capecitabine
 Temozolomide
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents