Clinical Trials /

Sunitinib in Never-Smokers With Lung Adenocarcinoma

NCT01829217

Description:

This research study is a Phase II clinical trial, which tests the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific cancer. "Investigational" means that the drug is being studied. It also means that the FDA has not yet approved sunitinib for your type of cancer. Sunitinib has been approved by the FDA for treatment of gastrointestinal stromal tumors, advanced renal cell carcinoma and advanced pancreatic neuroendocrine tumors. While most chemotherapies work by interfering with cancer cell replication, sunitinib works by blocking certain protein signals within the cell. Because sunitinib works differently from standard intravenous chemotherapies, we call it a "targeted therapy." This drug has also been used in other research studies and information from those other research studies suggests that this agent may help to slow the growth of some NSCLC tumors. In this research study, we are looking to see if sunitinib may stop certain NSCLC tumors from growing. The study focuses on a type of NSCLC, adenocarcinoma, which has previously been found to be more sensitive to other kinds of oral targeted therapies. This study will focus specifically on (1) adenocarcinoma tumors that do not carry a mutation in a known cancer gene (EGFR, KRAS, or ALK) and occur in patients that never smoked (less than 100 cigarettes in their lifetime) or (2) adenocarcinoma tumors that have a mutation in the RET gene.

Related Conditions:
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Completed

Phase:

Phase 2

Trial Eligibility

Document

<span class="go-doc-concept go-doc-intervention">Sunitinib</span> in Never-Smokers With Lung Adenocarcinoma

Title

  • Brief Title: Sunitinib in Never-Smokers With Lung Adenocarcinoma
  • Official Title: A Phase II Trial of Sunitinib in Never-smokers With Lung Adenocarcinoma: Identification of Oncogenic Alterations Underlying Sunitinib Sensitivity
  • Clinical Trial IDs

    NCT ID: NCT01829217

    ORG ID: 13-086

    Trial Conditions

    Lung Cancer

    Trial Interventions

    Drug Synonyms Arms
    Sunitinib Sunitinib

    Trial Purpose

    This research study is a Phase II clinical trial, which tests the safety and effectiveness
    of an investigational drug to learn whether the drug works in treating a specific cancer.
    "Investigational" means that the drug is being studied. It also means that the FDA has not
    yet approved sunitinib for your type of cancer.

    Sunitinib has been approved by the FDA for treatment of gastrointestinal stromal tumors,
    advanced renal cell carcinoma and advanced pancreatic neuroendocrine tumors. While most
    chemotherapies work by interfering with cancer cell replication, sunitinib works by blocking
    certain protein signals within the cell. Because sunitinib works differently from standard
    intravenous chemotherapies, we call it a "targeted therapy." This drug has also been used in
    other research studies and information from those other research studies suggests that this
    agent may help to slow the growth of some NSCLC tumors.

    In this research study, we are looking to see if sunitinib may stop certain NSCLC tumors
    from growing. The study focuses on a type of NSCLC, adenocarcinoma, which has previously
    been found to be more sensitive to other kinds of oral targeted therapies. This study will
    focus specifically on (1) adenocarcinoma tumors that do not carry a mutation in a known
    cancer gene (EGFR, KRAS, or ALK) and occur in patients that never smoked (less than 100
    cigarettes in their lifetime) or (2) adenocarcinoma tumors that have a mutation in the RET
    gene.

    Detailed Description

    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 Cycle 1, you will be seen every two weeks on Days 1, 15 and 29 and during Cycles 2-3,
    you will be seen on Days 1 and 29. Starting with Cycle 4, 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.

    Trial Arms

    Name Type Description Interventions
    Sunitinib Experimental 42 day cycle, taken orally every day for the first 28 days followed by 14 days off Sunitinib

    Eligibility Criteria

    Inclusion Criteria:

    - Histologically or cytologically confirmed advanced (stage IV or recurrent) non-small
    cell lung cancer

    - Adenocarcinoma histology of any variant, including adenosquamous histology

    - Wild-type for mutations in EGFR, KRAS and ALK

    - < 100 cigarettes smoked lifetime OR known to harbor a RET rearrangement

    - Measurable disease

    - At least one prior systemic therapy (adjuvant or palliative)

    - Life expectancy of greater than 4 weeks

    - Adequate tumor tissue for the correlative analyses on study, or must undergo a biopsy
    to obtain adequate tissue

    Exclusion Criteria:

    - Pregnant or breastfeeding

    - Chemotherapy within 4 weeks of entering study, or lack of recover from adverse events
    to grade 1 or less due to systemic agents administered more than 4 weeks earlier

    - Radiation therapy within 2 weeks prior to entering study

    - Major surgery within 4 weeks prior to entering the study

    - Receiving any other investigational agents

    - Known untreated, symptomatic or progressive brain metastases; presence of
    carcinomatous meningitis; history of intracranial hemorrhage or brain metastases
    requiring chronic steroids

    - History of allergic reactions attributed to compounds of similar chemical or biologic
    composition to sunitinib

    - Use of certain inhibitors and inducers of CYP3A4

    - Grade 3 or 4 hemoptysis or hemorrhage within 4 weeks prior to study entry

    - History of significant bleeding disorder unrelated to cancer

    - Poorly controlled hypertension

    - Severe cardiovascular disease

    - Prolongation of corrected QT interval

    - History of a different malignancy except: cervical cancer in situ, basal or squamous
    cell carcinoma of the skin, low risk centralized prostate cancer

    - HIV positive on combination antiretroviral therapy

    Minimum Eligible Age: 18 Years

    Maximum Eligible Age: N/A

    Eligible Gender: Both

    Primary Outcome Measures

    Evaluate Objective Response Rate to Sunitinib

    Secondary Outcome Measures

    Identify Oncogenic Alterations

    Explore Activity of Sunitinib in Lung Cancers with RET Rearrangement

    Trial Keywords