New Clinical Trial Testing Chemotherapy After Surgery in High-Risk pNETs

New Clinical Trial Testing Chemotherapy After Surgery in High-Risk pNETs

A new phase II clinical trial is exploring the effects of two approved chemotherapy drugs administered after surgery to treat adult patients who have high-risk, well-differentiated pancreatic neuroendocrine tumors (pNETS).

Chemotherapy drugs such as capecitabine and temozolomide work in different ways to stop the growth of tumor cells either by killing the cells, stopping them from dividing, or stopping their spread. Giving capecitabine and temozolomide after surgery could prevent or delay the return of cancer in patients with high-risk well-differentiated pNETs.

The randomized study will evaluate recurrence-free survival in participants with resected pNETs who are randomized to treatment with capecitabine and temozolomide compared to observation only. The study will also evaluate the overall survival and the safety and tolerability of the treatment approach.

Patients in the study will receive capecitabine on days 1-14 and temozolomide on days 10-14, with the treatment repeating every 28 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.

Approximately 141 adult patients are expected to take part in the clinical trial at six sites.

Inclusion and Exclusion Criteria

Among the criteria for participating in the study, patients must have:

  • A diagnosis of well-differentiated pNET that was resected between 14 and 90 days prior to registration in the study. Patients must also have scan without evidence of metastatic disease.
  • Resection that was an R0 or R1 per treating investigator’s assessment and/or pathology report
  • Ki-67 testing performed between 14 and 90 days prior to registration in the study. The result must be >= 3% and =< 55%.
  • Resected pNETS must have a Zaidi score of >= 3 (for patients with localized resected pNETS)
  • Received resection/ablation of liver oligo-metastatic disease (up to 5 liver metastases) at the time of well-differentiated pNET resection
  • Zubrod performance status of 0-2

Other criteria apply to determine a patient’s eligibility for the study.

NET patients with the following are not eligible to take part in the trial:

  • Unresected or unablated metastatic disease
  • Clinically apparent central nervous system metastases or carcinomatous meningitis
  • Prior neoadjuvant therapy for treatment of pancreatic neuroendocrine tumor (use of somatostatin analogs prior to surgery is permitted)
  • Somatostatin analogs after surgery
  • Planning to receive warfarin while on protocol treatment (other anticoagulants are allowed)
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to temozolomide or capecitabine
  • Absorption issues that would limit the ability to absorb study agents
  • An arterial thromboembolic event, unstable angina, or myocardial infarction within 12 months prior to registration
  • Active or uncontrolled infection
  • Serious medical or psychiatric illness that could affect study participation in the judgement of the treating investigator
  • Pregnant, due to the possibility of harm to the fetus

Heloisa Soares, MD, PhD, of the University of Utah Health, serves as principal investigator of the study sponsored by the Southwest Oncology Group in collaboration with the National Cancer Institute. For additional information about the study, contact Arun Athithan, CCRP, the clinical research coordinator for the study (arun.athithan@hci.utah.edu; 801-587-4624).

Next Steps

Additional information on the study can be found at clinicaltrials.gov. Interested participants should talk to their treatment team about eligibility and determine if the study is aligned with their treatment goals.

 

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