Phase II Study of Ziv-aflibercept in Patients With Advanced, Progressive Carcinoid Tumors
If you are willing to participate in this study you will be asked to undergo some screening
tests and procedures to confirm that you are eligible. Many of these tests and procedures
are likely to be part of regular cancer care and may be done even if it turns out that you
do not take part in the research study. If you have had some of these tests or procedures
recently, they may or may not have to be repeated. These tests and procedures include: a
medical history, physical examination, CT or MRI, blood tests, serum chromogranin A, urine
tests, 24-hour urine collection, pregnancy test and an electrocardiogram. If these tests
show that you are eligible to participate in the research study, you will begin the study
treatment. If you do not meet the eligibility criteria, you will not be able to participate
in this research study.
If you meet the requirements for this study and you agree to continue your participation,
you will receive Ziv-aflibercept every two weeks. Each dose of Ziv-aflibercept consists of
an approximately 60 minutes infusion (through a needle into a vein). You will also receive
an injection of Octreotide LAR (long acting release) monthly as part of your treatment for
carcinoid tumor. This injection will be given to you by a nurse in your buttock. You may
already be on Octreotide LAR. In that case, you will continue taking it at the same dose and
You will need to come to the clinic every two weeks while participating in this study. Each
cycle is 28 days.
The following tests and procedures will be performed on Days 1 and 15 of each cycle:
questions about your health, physical exam (Day 1 of each cycle only), vital signs, blood
tests, pregnancy test (Day 1 of each cycle only).
Urine tests will be performed every other cycle.
The following tests and procedures will be done at the end of every third cycle: CT scan or
MRI, Serum Chromogranin A, 24-hour urine collection.
After the final dose of the study drug the following tests and procedures will be performed:
questions about your general health, physical exam, vital signs, blood tests, pregnancy
test, EKG, Serum Chromogranin A, 24-hour urine collection.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression Free Survival
To evaluate the progression-free survival (PFS) duration of patients with metastatic, unresectable, progressive carcinoid tumors treated with Ziv-aflibercept
United States: Food and Drug Administration
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Brigham and Women's Hospital||Boston, Massachusetts 02115|
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|