CapTem + Y90 for Neuroendocrine Cancer

(CapTemY90 Trial)

Recruiting in Palo Alto (17 mi)

+2 other locations

Overseen by Michael Soulen, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: University of Pennsylvania

Must not be taking: Investigational agents

Disqualifiers: Previous embolization, Uncontrolled illness, Pregnancy, others

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Do I need to stop my current medications to join the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, you must have stopped any chemotherapy or radiotherapy at least 4 weeks before joining the trial.

What data supports the effectiveness of the CapTem treatment for neuroendocrine cancer?

Research shows that the combination of capecitabine and temozolomide (CAPTEM) is effective in treating advanced neuroendocrine tumors, with high response rates reported in multiple studies. This suggests that the CapTem treatment could be beneficial for patients with neuroendocrine cancer.

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Is the CapTem + Y90 treatment generally safe for humans?

The combination of capecitabine and temozolomide (CapTem) has been studied for safety in patients with neuroendocrine tumors and other cancers, showing it is generally safe but may have risks like infections and blood-related side effects. More research is needed to fully understand rare toxicities and long-term effects.

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How is the CapTem + Y90 treatment different from other treatments for neuroendocrine cancer?

The CapTem + Y90 treatment is unique because it combines oral chemotherapy drugs, capecitabine and temozolomide, with Y90 radioembolization, a targeted radiation therapy, to treat neuroendocrine tumors, especially those that have spread to the liver. This combination leverages the radiosensitizing properties of the drugs to enhance the effectiveness of the radiation, potentially improving response rates and survival outcomes compared to standard treatments.

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Eligibility Criteria

Adults over 18 with Grade 2 neuroendocrine tumors and liver metastases that can't be removed by surgery. They should have a life expectancy of more than 6 months, stable health, and not have had chemotherapy or radiotherapy in the last 4 weeks. Liver function must be within certain limits, and they need to use effective contraception if capable of childbearing.

Inclusion Criteria

Less than half of my liver is affected by cancer.

I have a grade 2 neuroendocrine tumor with liver metastases that cannot be surgically removed.

My liver is working well, based on recent tests.

Exclusion Criteria

Contraindicated for both contrast-enhanced MRI and CT

I cannot take capecitabine or temozolomide due to adverse reactions.

I cannot have a specific liver cancer treatment due to high risk of complications.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Capecitabine and Temozolomide (CapTem) and undergo Yttrium-90 radioembolization. Capecitabine is administered 750 mg/m2 twice daily orally for 14 days and Temozolomide 200 mg/m2 orally on Days 10-14, with 14 days between cycles. TARE is performed on Day 7 of Cycle 2 and, if needed, on Day 7 of Cycle 3 or 4.

Until progression or intolerance

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments including tumor markers and quality of life evaluations every 3 months for 24 months.

24 months

Participant Groups

The trial is testing how well patients with specific liver tumors respond to a combination therapy using Capecitabine, Temozolomide (oral medications), and Y90 radioembolization compared to previous treatments. It's a Phase 2 study focusing on whether this mix can safely improve disease control.

Group I: Oral CapTem + Y90 Radioembolization Experimental Treatment 3 Interventions

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.

Capecitabine Oral Product is already approved in European Union, United States, Canada for the following indications:

🇪🇺 Approved in European Union as Xeloda for:

• Breast cancer
• Gastric cancer
• Colorectal cancer

🇺🇸 Approved in United States as Xeloda for:

• Metastatic colorectal cancer
• Breast cancer

🇨🇦 Approved in Canada as Xeloda for:

• Metastatic colorectal cancer
• Breast cancer

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

UC San Diego La Jolla, CA

Roswell Park Comprehensive Cancer Center Buffalo, NY

University of Pennsylvania Philadelphia, PA

Who Is Running the Clinical Trial?

University of Pennsylvania Lead Sponsor

Abramson Cancer Center at Penn Medicine Lead Sponsor

Abramson Cancer Center of the University of Pennsylvania Lead Sponsor

University of California, San Diego Collaborator

University of Miami Sylvester Comprehensive Cancer Center Collaborator

Roswell Park Cancer Institute Collaborator

CARTI Collaborator

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Activity and Safety of Standard and Prolonged Capecitabine/Temozolomide Administration in Patients with Advanced Neuroendocrine Neoplasms. [2020] Capecitabine and temozolomide combination (CAPTEM) is associated with high response rates in patients with advanced neuroendocrine neoplasms (NENs). We evaluated the real-world activity and safety of CAPTEM from 3 NEN centers.

2. England pubmed.ncbi.nlm.nih.gov

Efficacy of Capecitabine and Temozolomide Regimen in Neuroendocrine Tumors: Data From the Turkish Oncology Group. [2023] This study aims to report the efficacy and safety of capecitabine plus temozolomide (CAPTEM) across different lines of treatment in patients with metastatic neuroendocrine tumors (NETs).

3. New Zealand pubmed.ncbi.nlm.nih.gov

Capecitabine and Temozolomide (CAPTEM) in Advanced Neuroendocrine Neoplasms (NENs): A Systematic Review and Pooled Analysis. [2023] Retrospective studies and single center experiences suggest a role of capecitabine combined with temozolomide (CAPTEM) in neuroendocrine tumors (NENs).

4. United States pubmed.ncbi.nlm.nih.gov

The optimal duration of capecitabine plus temozolomide in patients with well-differentiated pancreatic NETs with or without maintenance therapy. [2022] The optimal duration of capecitabine combined with temozolomide (CapTem) for metastatic pancreatic neuroendocrine tumours (PanNETs) remains controversial. The present study aimed to assess the activity and safety of prolonged CapTem and Cap maintenance therapy in patients with metastatic PanNETs.

5. United States pubmed.ncbi.nlm.nih.gov

Efficacy and Toxicity Analysis of Capecitabine and Temozolomide in Neuroendocrine Neoplasms. [2023] The capecitabine/temozolomide (CAPTEM) regimen has significant activity in advanced neuroendocrine tumors (NETs). Questions exist regarding activity in pancreatic versus nonpancreatic NETs, risk of opportunistic infections, long-term myelotoxicity, and safety of prolonged treatment duration. Analysis of large patient cohorts is needed for the evaluation of rare toxicities and assessment of risk factors.

6. England pubmed.ncbi.nlm.nih.gov

A phase II trial of capecitabine in previously untreated patients with advanced and/or metastatic gastric cancer. [2022] Capecitabine (Xeloda) is a novel, oral, selectively tumor-activated fluoropyrimidine with proven activity in the treatment of advanced colorectal cancer. This trial was conducted to evaluate the efficacy, safety and feasibility of capecitabine in previously untreated patients with advanced and/or metastatic gastric cancer, with a view to replacing 5-fluorouracil (5-FU) in such patients.

7. United States pubmed.ncbi.nlm.nih.gov

Phase I study of capecitabine in combination with temozolomide in the treatment of patients with brain metastases from breast carcinoma. [2018] A single-institution Phase I clinical trial was conducted to determine the maximum tolerated dose (MTD) and define the safety profile of temozolomide and capecitabine when used in combination to treat brain metastases from breast cancer.

8. United States pubmed.ncbi.nlm.nih.gov

Integrated Capecitabine-Temozolomide with Radioembolization for Liver-Dominant G2 NETs: Long-Term Outcomes of a Single-Institution Retrospective Study. [2023] Capecitabine-Temozolomide (CapTem) is an oral chemotherapy regimen for NETs. Both drugs are radiosensitizers. Integrating CapTem and Y90 transarterial radioembolization (TARE) in patients with grade 2 neuroendocrine tumor (NET) liver metastases achieved an encouraging objective response rate (ORR) and progression-free survival (PFS) in a feasibility study. This study expands that report to a larger cohort with longer follow-up.