Sunitinib in Never-Smokers With Lung Adenocarcinoma

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Dana-Farber Cancer Institute
Sponsor:
Information provided by (Responsible Party):
Geoffrey Oxnard, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT01829217
First received: April 9, 2013
Last updated: February 5, 2014
Last verified: February 2014
  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.


Condition Intervention Phase
Lung Cancer
Drug: Sunitinib
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Trial of Sunitinib in Never-smokers With Lung Adenocarcinoma: Identification of Oncogenic Alterations Underlying Sunitinib Sensitivity

Resource links provided by NLM:


Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:
  • Evaluate Objective Response Rate to Sunitinib [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Identify Oncogenic Alterations [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    To identify oncogenic alterations underlying sensitivity to sunitinib through performing next-generation sequencing (NGS) of lung cancers treated with sunitinib

  • Explore Activity of Sunitinib in Lung Cancers with RET Rearrangement [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    To explore the activity of sunitinib in lung cancers known to harbor a RET rearrangement


Estimated Enrollment: 35
Study Start Date: May 2013
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sunitinib
42 day cycle, taken orally every day for the first 28 days followed by 14 days off
Drug: Sunitinib

  Hide Detailed Description

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01829217

Contacts
Contact: Geoffrey Oxnard, MD 6176326234 geoffrey_oxnard@dfci.harvard.edu

Locations
United States, Massachusetts
Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: Geoffrey Oxnard, MD    617-632-6234    geoffrey_oxnard@dfci.harvard.edu   
Principal Investigator: Geoffrey Oxnard, MD         
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02215
Contact: Geoffrey Oxnard, MD    617-632-6234    geoffrey_oxnard@dfci.harvard.edu   
Principal Investigator: Geoffrey Oxnard, MD         
Beth Isreal Deaconess Medical Center Not yet recruiting
Boston, Massachusetts, United States, 02215
Contact: Daniel Costa, MD, PhD    617-667-9236    dcosta@bidmc.harvard.edu   
Principal Investigator: Daniel Costa, MD, PhD         
Massachusetts General Hospital Not yet recruiting
Boston, Massachusetts, United States, 02214
Contact: Rebecca Heist, MD    617-726-1838    rheist@partners.org   
Principal Investigator: Rebecca Heist, MD         
Sponsors and Collaborators
Dana-Farber Cancer Institute
Investigators
Principal Investigator: Geoffrey Oxnard, MD Dana-Farber Cancer Institute
  More Information

No publications provided

Responsible Party: Geoffrey Oxnard, MD, Prinicipal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT01829217     History of Changes
Other Study ID Numbers: 13-086
Study First Received: April 9, 2013
Last Updated: February 5, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Adenocarcinoma
Lung Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Sunitinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on August 26, 2014