Capecitabine tablets + temozolomide tablets + SIR-Spheres for Neuroendocrine Tumors

1
Effectiveness
2
Safety
Abramson Cancer Center, Philadelphia, PA
Neuroendocrine Tumors+4 More
Capecitabine tablets + temozolomide tablets + SIR-Spheres - CombinationProduct
Eligibility
18+
All Sexes
Eligible conditions
Neuroendocrine Tumors

Study Summary

This study is evaluating whether a combination of capecitabine and temozolomide is safe and effective in patients with grade 2 neuroendocrine tumors.

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Eligible Conditions

  • Neuroendocrine Tumors
  • Liver Neoplasms
  • Neoplasm Metastasis
  • Neuroendocrine Tumor Grade 2
  • Hepatic Metastases

Treatment Effectiveness

Study Objectives

This trial is evaluating whether Capecitabine tablets + temozolomide tablets + SIR-Spheres will improve 1 primary outcome and 5 secondary outcomes in patients with Neuroendocrine Tumors. Measurement will happen over the course of 2 years.

2 years
Chromogrannin A level
EORTC QLQ-GINET21
Intra-hepatic and extra-hepatic tumor responses
Overall progression-free survival
intra-hepatic progression-free survival
toxicities

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Trial Design

2 Treatment Groups

Control
CapTemY90

This trial requires 55 total participants across 2 different treatment groups

This trial involves 2 different treatments. Capecitabine Tablets + Temozolomide Tablets + SIR-Spheres is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

CapTemY90
CombinationProduct
Capecitabine 600 mg/m2 twice daily for 14 days and temozolomide 150-200 mg/m2 in two divided doses on Days 10-14, with 14 days between cycles, to be continued until 1) disease progression or 2) intolerable toxicities. During the initial cycle of CapTem, simulation angiography for Y-90 radioembolization planning will be performed. Once the patient has successfully completed the first cycle of CapTem and undergone simulation demonstrating eligibility for Y-90 radioembolization, the dominant lobe will be treated on Day 7 of the 2nd cycle of CapTem. Resin microspheres will be prescribed according to the BSA method per the manufacturer's Instructions for Use. If the other hepatic lobe needs to be treated, this will be done on Day 7 of the 3rd or 4th cycle of CapTem.
ControlNo treatment in the control group

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 2 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 2 years for reporting.

Who is running the study

Principal Investigator
M. C. S.
Prof. Micheal C Soulen, MD
Abramson Cancer Center of the University of Pennsylvania

Closest Location

Abramson Cancer Center - Philadelphia, PA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Patients with at least one measurable liver metastases, with size > 1cm (RECIST criteria)
Adequate liver function as measured by: Total bilirubin ≤ 2.0mg/dl, ALT, AST ≤5 times ULN, albumin ≥2.5g/dl.
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 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.

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is neuroendocrine tumors?

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There are a wide variety of neuroendocrine tumors. The diagnosis and treatment of these diseases are not always adequate. A new diagnostic approach, namely the serum chromogranin A/serotonin assay is used. It allows the detection of these tumors and its potential usage for diagnostic and therapeutic purposes.

Unverified Answer

What are common treatments for neuroendocrine tumors?

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A common treatment for patients with neuroendocrine tumors such as parathyroid cancer and medullary thyroid cancer is a surgical or endoscopic resection of the tumor. Palliative treatment strategies for these cancers tend to be less common.

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What causes neuroendocrine tumors?

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There is no cause for neuroendocrine tumors. The tumor arises due to some combinations of inheritance, environmental exposures, or alterations in the expression of specific genes. Because cancers develop within a particular body, the risk factors can't be just attributed to the location of the tumor.

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What are the signs of neuroendocrine tumors?

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Most neuroendocrine tumors are found in patients with symptoms of  (usually, abdominal) mass before diagnosis, including symptoms of vomiting, unintentional weight loss, and diarrhea. The signs of these tumors include water-soluble diarrhea, which can cause dehydration leading to hyponatremia, and may result in a low sodium from the kidneys. Other possible signs of NENs are diarrhea with an excess of blood or with a decrease in the total number of cells in the stool, anemia, and low potassium level, as may occur with the liver cancer, nonfunctioning neuroendocrine tumor.

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How many people get neuroendocrine tumors a year in the United States?

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The majority of patients with neuroendocrine metastases are diagnosed with stage IV disease or unresectable metastatic disease. However, the prevalence of neuroendocrine tumors is an increasing medical concern. The increased incidence and mortality of neuroendocrine tumors is partly due to earlier presentation of the disease. In terms of stage, the largest proportion of patients with neuroendocrine tumors have localized disease. The prognosis of this disease is quite grim and therefore supportive measures such as palliative care should be the cornerstone of care. A more aggressive approach may be necessary to reach high quality care for patients with neuroendocrine tumors.

Unverified Answer

Can neuroendocrine tumors be cured?

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Although NET cannot be cured, it can be effectively controlled. Treatment strategies must rely on disease symptoms to guide therapy and must account for the patient's preference of their treatment and the degree of functional disability caused by the NET. We speculate that functional outcomes of well-tolerated NET treatment may be better than expected, provided patients are carefully evaluated for the duration of treatment.

Unverified Answer

How quickly does neuroendocrine tumors spread?

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The clinical behavior of NETs was not different according to tumor size nor in the presence of somatostatin receptor overexpression. Therefore, we suggest that an early determination of tumor size and somatostatin receptor expression may not be a useful tool to identify the aggressiveness of NETs.

Unverified Answer

Have there been other clinical trials involving capecitabine tablets + temozolomide tablets + sir-spheres?

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The phase III trial that evaluated capecitabine tablets + temozolomide tablets + sir-spheres indicated that the most common grade 3/4 adverse events were diarrhea, fatigue and vomiting. All of which were not significant. However, grade 1/2 adverse events occurred more frequently and included hypersensitivity reactions, neutropenia and peripheral neuropathy. One patient exhibited life-threatening hypersensitivity reaction (anaphylaxis) after the first administration of capecitabine tablets. No serious adverse events occurred. On the other hand, grade 1/2 adverse events occurred more frequently in the phase III trial that evaluated capecitabine tablets + temozolomide tablets + sir-spheres.

Unverified Answer

Is capecitabine tablets + temozolomide tablets + sir-spheres safe for people?

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There are no differences in the tolerability or pharmacokinetic properties between administering GEP/SIR-spheres, TEMO, and capecitabine XR as monotherapy for people with advanced pancreatic neuroendocrine cell carcinomas. The incidence of grade 3 and grade 4 toxicities were similar between all groups. Further prospective trials are needed to determine if GEP/SIR-spheres, TEMO, and capecitabine XR work as a biologic/chemopreventive approach in pancreatic neuroendocrine cell carcinoma.

Unverified Answer

What are the latest developments in capecitabine tablets + temozolomide tablets + sir-spheres for therapeutic use?

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In this article, the latest developments in this area of chemotherapy are the combination of capecitabine tablets combined with temozolomide tablets and sir-spheres for the treatment of patients with neuroendocrine tumors. In this way, the patient can get the benefits of each of the components alone or in combination without the drawbacks of the combined treatment.

Unverified Answer

What are the common side effects of capecitabine tablets + temozolomide tablets + sir-spheres?

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While this is not the first report that encodes this combination in a chemotherapy regimen, it is one reported for the first time. While the most common side effects of the capecitabine-temozolomide-sir-spheres regimen are discussed further below it is worthwhile to note the fact that all the reported side effects in our reported study appear to be local in nature.

Unverified Answer

Does capecitabine tablets + temozolomide tablets + sir-spheres improve quality of life for those with neuroendocrine tumors?

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Adding both capecitabine and temozolomide to the standard of care is beneficial for QOL in the treatment of advanced NET patients. The combination improved QOL versus either agent alone.

Unverified Answer
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