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

  Show Detailed Description

  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
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         
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         
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         
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
Carcinoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Sunitinib
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Antineoplastic Agents
Growth Inhibitors
Growth Substances
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 30, 2014