A Phase II Trial of Sunitinib in Never-smokers With Lung Adenocarcinoma: Identification of Oncogenic Alterations Underlying Sunitinib Sensitivity
If you are willing to participate in this research 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
will include: a medical history, complete physical exam, performance status, assessment of
your tumor, routine blood tests, urine pregnancy test, urine test, electrocardiogram, and an
echocardiogram. In order to screen for and participate in this study, your tumor sample must
have been tested for genetic alterations in EGFR, KRAS and ALK and been found to have
negative results. Alternatively, you must have had testing that determined that your tumor
sample has a RET mutation. You will not be eligible to screen on this study unless these
testing requirements have already been met. In addition to the above requirements, before
starting other screening for the study, it must be confirmed that there is adequate tumor
tissue left from a previous surgery or biopsy for required study-related tests. This tumor
specimen is stored in a pathology department in a paraffin block. If adequate tumor tissue
isn't available, you may be able to have a new biopsy of our tumor to obtain this tissue. If
the required tests and procedures show that you are eligible to participate in the research
study, you will begin the study drug. If you do not meet all of the eligibility criteria,
you will not be able to participate in this research study.
If you take part in this research study, you will be given a study drug-dosing diary for
each treatment cycle. Each treatment cycle lasts 42 days (6 weeks), during which time you
will be taking the study drug daily (at home, by mouth) for 28 days (four weeks), followed
by 2 weeks off sunitinib. On Day 1 of each cycle, you will be given a 28 days supply of
study drug. The diary that you will be given on Day 1 of each cycle will also include
special instructions for taking the sunitinib.
There is a possibility that the following tests or procedures may need to be done at times
other than those listed below. These may be done if your research doctor determines they are
medically necessary to monitor your illness or any side effects you may be experiencing. It
is important that you call your research doctor if at any time you are experiencing side
effects you cannot tolerate.
During Cycles 1-3, you will be seen every two weeks on Days 1, 15 and 29 and during Cycles
4-6, you will be seen on Days 1 and 29. Starting with Cycle 7, you will only have a clinic
visit on DAy 1 of every six-week cycle.
During all cycles you will have a physical exam and you will be asked questions about your
general health and specific questions about any problems that you might be having and any
medications you may be taking. At different times throughout the study you will also undergo
the following: side effect review, current medication review, weight, vital signs, physical
exam, performance status, blood sample collection, review of drug diary and ECG.
We will assess your tumor(s) by CT scans ever six weeks (at the end of each cycle). CT scans
will also be repeated at the End of Study if they weren't done within the previous 30 days.
During the study, your tumor sample will be tested and analyzed for genomic changes (changes
in your tumor genes) that may be associated with the effectiveness of sunitinib. As a
comparison, your blood will also be tested for changes in these genes. These genomic tests
will be for research only and you will not be informed of their results. If you withdraw
from the study and yuor tumor sample has already been tested, the remaining tumor material
will be sent to the pathology department that first tested your tissue for cancer. However,
the collected information related to your participation in this study and your genomic
testing will remain part of the overall research data and used for the analysis.
We would like to keep track of your medical condition for the rest of your life. We would
like to do this by calling you on the telephone once a year to see how you are doing.
Keeping in touch with you and checking your condition every year helps us look at the
long-term effects of the research study.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Evaluate Objective Response Rate to Sunitinib
To evaluate the objective response rate (ORR) to sunitinib in never-smokers with lung cancers that are wild-type for EGFR, KRAS, and ALK in a single-arm phase II trial
Geoffrey Oxnard, MD
Dana-Farber Cancer Institute
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|
|Beth Isreal Deaconess Medical Center||Boston, Massachusetts 02215|