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mTOR Inhibitor
Radioactive Drug vs Everolimus for Neuroendocrine Cancer
Phase 2
Recruiting
Led By Simron Singh
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from objective progression on everolimus to objective progression or death from any cause after cross-over to receive 177lu-dotatate, assessed up to 3 years
Awards & highlights
No Placebo-Only Group
Summary
This trial compares a radioactive drug linked to a peptide receptor with a drug that stops cancer cells from reproducing to treat neuroendocrine tumors.
Who is the study for?
Adults with metastatic, well-differentiated midgut neuroendocrine tumors previously treated with PRRT and showing progression can join. They must have good organ function, no severe ongoing side effects from prior treatments, and an ECOG performance status of <=2. Women of childbearing potential must agree to use effective contraception.
What is being tested?
The trial compares retreatment using a radioactive peptide (177Lu-DOTATATE PRRT) against the usual treatment with everolimus in patients whose midgut NET has spread and cannot be surgically removed. The goal is to see which method better controls tumor growth.
What are the potential side effects?
Possible side effects include radiation-related risks like bone marrow suppression, kidney damage from 177Lu-DOTATATE; everolimus may cause mouth sores, infections due to immune suppression, lung problems, delayed wound healing.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from objective progression on everolimus to objective progression or death from any cause after cross-over to receive 177lu-dotatate, assessed up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from objective progression on everolimus to objective progression or death from any cause after cross-over to receive 177lu-dotatate, assessed up to 3 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Progression-free survival (PFS)
Secondary study objectives
Objective response rate (ORR)
Overall survival (OS)
Post progression survival (PPS)
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm I (177Lu-DOTATATE)Experimental Treatment5 Interventions
Patients receive 177Lu-DOTATATE IV Q8W. Treatment repeats for two cycles in the absence of disease progression or unacceptable toxicities. Patients also undergo CT scan and collection of blood samples while on study.
Group II: Arm II (everolimus)Active Control5 Interventions
Patients receive everolimus PO QD. Treatment continues in the absence of disease progression or unacceptable toxicities. Patients whose cancer worsens may cross over to ARM I. Patients also undergo CT scan and collection of blood samples while on study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biospecimen Collection
2004
Completed Phase 3
~2030
Computed Tomography
2017
Completed Phase 2
~2790
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,958 Previous Clinical Trials
41,112,480 Total Patients Enrolled
81 Trials studying Neuroendocrine Tumors
43,662 Patients Enrolled for Neuroendocrine Tumors
Simron SinghPrincipal InvestigatorCanadian Cancer Trials Group
2 Previous Clinical Trials
27 Total Patients Enrolled
1 Trials studying Neuroendocrine Tumors
17 Patients Enrolled for Neuroendocrine Tumors
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have used medication to manage carcinoid syndrome symptoms.My heart condition is not well-managed and is severe.I am 18 years old or older.I have a low-grade cancer originating from the midgut.I've had 3 or 4 rounds of PRRT therapy with a specific dose in the last year.I can attend all treatment, check-up, and follow-up appointments.I cannot swallow pills or have a gut condition affecting drug absorption.I have brain metastases that have not been treated.My cancer has grown after previous radiation therapy.I will take a pregnancy test if I can have children.I can get everolimus for my treatment.I am HIV positive, on treatment, and my viral load is undetectable.I have not had major surgery in the last 6 weeks.I have a serious health condition that isn't managed with treatment.I can take care of myself and am up and about more than 50% of my waking hours.I have another cancer that does not affect my current treatment's safety or effectiveness.
Research Study Groups:
This trial has the following groups:- Group 1: Arm I (177Lu-DOTATATE)
- Group 2: Arm II (everolimus)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.