Study on Cabozantinib for Advanced Pancreatic Neuroendocrine and Carcinoid Tumors
Sponsor: National Cancer Institute (NCI)
ClinicalTrials ID:NCT03375320
This clinical trial is testing the effectiveness of the drug cabozantinib compared to a placebo in treating advanced pancreatic neuroendocrine and carcinoid tumors that have spread and progressed after previous treatments.
Patient Parameters
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Program Overview
The purpose of this study is to see if cabozantinib, a chemotherapy drug, can help slow down the growth of advanced pancreatic neuroendocrine and carcinoid tumors compared to a placebo. Cabozantinib works by blocking specific proteins that help tumors grow. The study will also look at the safety of the drug and its impact on patients' quality of life.
Description
This study is divided into two main parts: Phase III trial comparing cabozantinib with a placebo in patients with advanced pancreatic neuroendocrine tumors and carcinoid tumors.
Primary Goals:
- To see if cabozantinib can improve the time patients live without their cancer getting worse compared to a placebo.
- To evaluate if cabozantinib can help patients live longer overall compared to a placebo.
Secondary Goals:
- To assess the safety and side effects of cabozantinib compared to a placebo.
- To measure how well the tumors respond to cabozantinib compared to a placebo.
- To explore how cabozantinib affects patients' quality of life and symptoms related to their disease.
Study Design:
- Participants will be randomly assigned to receive either cabozantinib or a placebo.
- Treatment cycles last 28 days, and patients will take the medication daily.
- Regular blood and urine tests, as well as imaging scans, will be conducted to monitor the disease.
- Patients can switch to cabozantinib if their disease progresses while on the placebo.
After completing the study treatment, patients will be followed up every 12 weeks until their disease progresses or they start a new cancer treatment, and then every 6 months for up to 8 years.
Eligibility Criteria
Inclusion Criteria
- Must have a confirmed diagnosis of well- or moderately-differentiated neuroendocrine tumors of pancreatic or non-pancreatic origin.
- Tumors must be advanced, meaning they have spread or cannot be removed by surgery.
- Must have measurable disease that has shown progression in the past year.
- Must have tried at least one previous treatment that did not work or was not tolerated.
- Must be 18 years or older and in relatively good health (ECOG performance status 0-2).
- Must have adequate blood counts and organ function as determined by specific medical tests.
- Women of childbearing potential must have a negative pregnancy test and agree to use contraception.
- Must not have had certain heart conditions, uncontrolled high blood pressure, or significant bleeding issues in the past 6 months.
- Must not have had prior treatment with cabozantinib.
- Must not have any other active cancer or be taking other investigational cancer treatments.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Katmai Oncology Group | 99508 | Anchorage | Alaska |
| Kingman Regional Medical Center | 86401 | Kingman | Arizona |
| Mayo Clinic Hospital in Arizona | 85054 | Phoenix | Arizona |
| Banner University Medical Center - Tucson | 85719 | Tucson | Arizona |
| University of Arizona Cancer Center-North Campus | 85719 | Tucson | Arizona |
| University of Arkansas for Medical Sciences | 72205 | Little Rock | Arkansas |
| Kaiser Permanente-Deer Valley Medical Center | 94531 | Antioch | California |
| PCR Oncology | 93420 | Arroyo Grande | California |
| Sutter Auburn Faith Hospital | 95602 | Auburn | California |
| Alta Bates Summit Medical Center-Herrick Campus | 94704 | Berkeley | California |
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