Everolimus 5 mg vs 10 mg/Daily for Patients With Neuroendocrine Tumors

Launched by AC CAMARGO CANCER CENTER · Jun 18, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a medication called everolimus, comparing two different doses: 5 mg and 10 mg taken daily. Everolimus is used to treat patients with advanced neuroendocrine tumors (NET), which are a type of cancer that can develop in various parts of the body, including the pancreas and lungs. The goal of this trial is to find out if the lower dose of 5 mg is just as effective as the higher dose of 10 mg in slowing down the progression of the disease while minimizing side effects.

To participate in this trial, individuals must have been diagnosed with Grade 1 or Grade 2 metastatic NET and have experienced disease progression despite receiving at least one prior treatment. Eligible participants should also be in generally good health with specific blood counts and liver function levels. Throughout the trial, participants will receive either the 5 mg or 10 mg dose of everolimus daily and will be monitored for their response to the treatment and any side effects that may occur. This study is currently recruiting participants and aims to provide valuable information about the best dosing strategy for treating neuroendocrine tumors.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Histological confirmation of well-differentiated Grade 1/Grade 2 NET from gastrointestinal, pancreatic, pulmonary or unknown primary sites.
• • Metastatic or locally advanced and unresectable disease, measurable by images
• • Disease progression by RECIST 1.1 in the last 6 months assessed by local investigators
• • At least one previous line of systemic treatment (suspended for more than 3 weeks).
• * Eastern Cooperative Oncology Group (ECOG) 0-2 o Good organ function:
• • Hemoglobin \> 8 g/dL
• • Neutrophils ≥ 1,500/mm³
• • Platelets \> 90,000/mm³
• • Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤ 2.5 x ULN \[upper limit of normal\] or ≤ 5 x ULN for patients with liver metastases
• • Bilirubin ≤ 1.5 x ULN, creatinine \< 1.5 mg/dL
• Exclusion Criteria:
• • Aggressive disease requiring cytotoxic therapy
• • Severe/uncontrolled comorbid conditions that deem participant unfit for everolimus therapy, as per investigators' judgement.
• • MiNEN