Comparing Capecitabine and Temozolomide to Lutetium Lu 177 Dotatate for Advanced Pancreatic Neuroendocrine Tumors

Sponsor: Alliance for Clinical Trials in Oncology

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05247905

Provider View

This study is testing two different treatments for advanced pancreatic neuroendocrine tumors that have spread or cannot be removed by surgery. It compares chemotherapy drugs capecitabine and temozolomide with a radioactive drug called lutetium Lu 177 dotatate to see which is more effective at killing tumor cells.

Patient Parameters

Program Overview

This clinical trial is exploring two treatment options for patients with advanced pancreatic neuroendocrine tumors that have spread or cannot be surgically removed. The study compares the effectiveness of chemotherapy drugs, capecitabine and temozolomide, which work by stopping tumor cells from growing and spreading, with a radioactive drug, lutetium Lu 177 dotatate, which targets tumor cells with radiation. The goal is to determine which treatment is better at reducing tumor size and controlling the disease.

Description

This study is designed to compare two treatment methods for advanced pancreatic neuroendocrine tumors: chemotherapy with capecitabine and temozolomide, and a radioactive treatment with lutetium Lu 177 dotatate. The main goal is to see which treatment helps patients live longer without the cancer getting worse. Researchers will also look at overall survival, how quickly the cancer responds to treatment, and any side effects. Patients will be randomly assigned to one of two groups: one group will receive lutetium Lu 177 dotatate every 8 weeks for up to 4 cycles, and the other group will take capecitabine and temozolomide in cycles every 4 weeks for up to 12 cycles. The study will also assess the impact of these treatments on patients' quality of life over 18 months.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with well-differentiated pancreatic neuroendocrine tumor (G1, G2, or well-differentiated G3).
  • Tumors can be functional or nonfunctional.
  • Cancer is advanced or cannot be removed by surgery.
  • Tumor must show somatostatin receptor positivity on a PET scan within the last year.
  • Patients must meet one of the following:
    • Untreated with symptoms like pain or hormone-related issues.
    • Previously treated with somatostatin analogs and showing disease progression.
    • Treated with somatostatin analogs and other therapies, with disease progression.
    • Treated with more than two therapies and have symptoms or hormone issues.
    • Disease progression within the last 4 months.
  • Must have measurable disease by CT or MRI.
  • Previous treatments with certain drugs are allowed if conditions are met.
  • Age 18 or older.
  • Good overall health with specific blood counts and organ function.
  • Can use somatostatin analogs during the study if conditions are met.

Exclusion Criteria

  • Patients with poorly differentiated neuroendocrine carcinoma are not eligible.
  • No prior treatment with specific chemotherapy or radioactive therapies for pancreatic neuroendocrine tumors.
  • Not pregnant or nursing, with a negative pregnancy test required for women of childbearing potential.
  • No untreated or unstable brain metastases.
  • No uncontrolled heart failure.
  • No significant uncontrolled medical, psychiatric, or surgical conditions.
  • No active second cancer, except for certain skin or cervical cancers.
  • No medical conditions affecting the ability to swallow or absorb oral medications.

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