Sunitinib Non Small Cell Lung Cancer Patients Over 70

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00864721
Recruitment Status : Completed
First Posted : March 19, 2009
Last Update Posted : May 21, 2014
Information provided by (Responsible Party):
US Oncology Research

Brief Summary:
The purpose of this research study is to find out what effects (good and bad) sunitinib has on patients and their NSCLC.

Condition or disease Intervention/treatment Phase
Non Small Cell Lung Cancer Drug: Sutent Phase 2

Detailed Description:
In this trial, the activity and tolerability of sunitinib malate (Sutent) will be examined in previously untreated elderly patients (>70 years old) felt not to be candidates for standard cytotoxic chemotherapy.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 63 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial of Sunitinib Malate in Previously Untreated NSCLC Patients Over the Age of 70
Study Start Date : February 2009
Actual Primary Completion Date : July 2012
Actual Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Sunitinib Malate
Sunitinib malate (Sutent) will be taken on an outpatient basis. Sunitinib malate (Sutent) should be taken at the dose of 37.5 mg/day by mouth; drug will only be taken Days 1-42 of each 42-day cycle.
Drug: Sutent
Sunitinib malate (Sutent) will be taken on an outpatient basis. Sunitinib malate (Sutent) should be taken at the dose of 37.5 mg/day by mouth; drug will only be taken Days 1-42 of each 42-day cycle.
Other Name: sunitinib malate

Primary Outcome Measures :
  1. The primary objective of the study is to evaluate efficacy, based on disease control rate (CR, PR, and SD at 6-weeks). [ Time Frame: 6 weeks ]

Secondary Outcome Measures :
  1. overall response rates,progression-free survival;time to progression,1-year survival, determining the tolerability and safety profile of sunitinib malate in this group of patients. [ Time Frame: course of the trial ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Has measurable, metastatic NSCLC, other elderly NSCLC patients over 70 years of age who are not felt to be candidates for standard chemotherapy at the discretion of the treating physician may also be enrolled as long as they meet the criteria; these "special consideration" patients enrollment in the study must be approved by Dr. Reynolds or DR. Smith in Dr. Reynolds absence. Patients must have a nonsquamous histology to be eligible for this study.
  • Has not received any prior chemotherapy for the current disease.
  • Has an ECOG Performance status. Is 70 years of age or older.Has resolution of all acute toxic effects of radiotherapy or surgical procedures to NCI CTCAE.
  • If fertile, patient (males only) has agreed to an acceptable method of birthcontrol to avoid pregnancy for the duration of the study and for a period of 2 months thereafter.
  • Has signed the most recent Patient Informed Consent Form. Has signed a Pate int Authorization Form.

Exclusion Criteria:

  • Has predominantly squamous NSCLC histology.
  • Had prior treatment with study drugs or other drugs.
  • Has a history of hypersensitivity to any component of the study drug. Has any evidence of an of antecedent hemoptysis, squamous histology, or ongoing anticoagulation or clotting diathesis.
  • Pre-existing hemoptysis Grade 2, cavitating lesions or clear proximity or involvement of blood vessels.
  • Has had major surgery or radiation therapy within 4 weeks of starting the study treatment.
  • Has had NCI CTCAE (Version 3.0) Grade 3-4 hemorrhage within 4 weeks of starting the study treatment.
  • Has a history of or known spinal cord compression, or carcinomatous meningitis, or evidence of symptomatic brain or leptomeningeal disease on screening CT or MRI scan; however, treated, stable, and asymptomatic brain metastases are allowed.
  • Has had any of the following within the 6 months prior to study drug administration: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, or pulmonary embolism. Has ongoing cardiac dysrhythmias of NCI CTCAE (Version 3.0) Grade 2.
  • Has prolonged QTc interval on baseline EKG. Has uncontrolled hypertension.
  • Has pre-existing thyroid abnormality with thyroid function that cannot be maintained in the normal range with medication.
  • Is receiving concurrent treatment on another clinical trial.
  • Supportive care trials or non-treatment trials, (eg, QOL), are allowed.
  • Is receiving concurrent immunotherapy, hormonal therapy, or radiation therapy.
  • Is receiving concurrent investigational therapy or has received such therapy within the past 30 days.
  • Has a serious uncontrolled intercurrent medical or psychiatric illness, including serious infection.
  • Has a history of other malignancy within the last 5 years (except cured basal cell carcinoma of skin and carcinoma in situ of uterine cervix), which could affect the diagnosis or assessment of any of the study drugs.
  • Is unable to comply with requirements of study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00864721

United States, Florida
Ocala Oncology Center
Ocala, Florida, United States, 34471
Cancer Centers of Florida, P.A.
Ocoee, Florida, United States, 34761
United States, Minnesota
Minnesota Oncology Hematology, P.A.
Minneapolis, Minnesota, United States, 55404
United States, North Carolina
Cancer Centers of North Carolina
Raleigh, North Carolina, United States, 27607
United States, Oregon
Willamette Valley Cancer Institute and Research Center
Eugene, Oregon, United States, 97401-8122
United States, South Carolina
Cancer Centers of the Carolinas
Greenville, South Carolina, United States, 29605
United States, Texas
Texas Oncology - Arlington South
Arlington, Texas, United States, 76014
Texas Oncology, P.A. - Bedford
Bedford, Texas, United States, 76022
Methodist Charlton Cancer Ctr.
Dallas, Texas, United States, 75237
Texas Cancer Center of Mesquite
Mesquite, Texas, United States, 75150
Texas Oncology Cancer Care and Research Center
Waco, Texas, United States, 76712
United States, Virginia
Virginia Oncology Associates
Norfolk, Virginia, United States, 23502
United States, Washington
Yakima Valley Mem Hosp/North Star Lodge
Yakima, Washington, United States, 98902
Sponsors and Collaborators
US Oncology Research
Principal Investigator: Craig H. Reynolds, MD US Oncology Research, LLC; Ocala Oncology Center

Responsible Party: US Oncology Research Identifier: NCT00864721     History of Changes
Other Study ID Numbers: 06-135
GA6181UU ( Other Identifier: Pfizer )
First Posted: March 19, 2009    Key Record Dates
Last Update Posted: May 21, 2014
Last Verified: May 2014

Keywords provided by US Oncology Research:
Untreated NSCLC in patients > 70

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors