Sunitinib Non Small Cell Lung Cancer Patients Over 70
Phase II Trial of Sunitinib Malate in Previously Untreated NSCLC Patients Over the Age of 70
2 other identifiers
interventional
63
1 country
13
Brief Summary
The purpose of this research study is to find out what effects (good and bad) sunitinib has on patients and their NSCLC.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Feb 2009
Typical duration for phase_2
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2009
CompletedFirst Submitted
Initial submission to the registry
March 18, 2009
CompletedFirst Posted
Study publicly available on registry
March 19, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2012
CompletedResults Posted
Study results publicly available
October 16, 2018
CompletedOctober 16, 2018
October 1, 2018
3.4 years
March 18, 2009
January 20, 2016
October 12, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Disease Control Rate (DCR)
Disease control rate = CR + PR + SD\>=6-weeks. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions. Stable Disease (SD) is defined as persistence of one or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits.
Every 6 weeks until progressive disease or death due to any cause, up to 36 month.
Secondary Outcomes (4)
Overall Response Rates (OR)
Every 6 weeks until progressive disease or death due to any causes, up to 36 months.
Progression-free Survival (PFS)
All patients were followed until progressive disease or death, up to 36 months.
1-year Overall Survival (OS) Rate.
All patients were followed until death or up to 36 months.
Time to Progression (TTP)
All patients were followed until progressive disease or death, up to 36 months.
Study Arms (1)
Sunitinib Malate
EXPERIMENTALSunitinib 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- US Oncology Researchlead
- Pfizercollaborator
Study Sites (13)
Ocala Oncology Center
Ocala, Florida, 34471, United States
Cancer Centers of Florida, P.A.
Ocoee, Florida, 34761, United States
Minnesota Oncology Hematology, P.A.
Minneapolis, Minnesota, 55404, United States
Cancer Centers of North Carolina
Raleigh, North Carolina, 27607, United States
Willamette Valley Cancer Institute and Research Center
Eugene, Oregon, 97401-8122, United States
Cancer Centers of the Carolinas
Greenville, South Carolina, 29605, United States
Texas Oncology - Arlington South
Arlington, Texas, 76014, United States
Texas Oncology, P.A. - Bedford
Bedford, Texas, 76022, United States
Methodist Charlton Cancer Ctr.
Dallas, Texas, 75237, United States
Texas Cancer Center of Mesquite
Mesquite, Texas, 75150, United States
Texas Oncology Cancer Care and Research Center
Waco, Texas, 76712, United States
Virginia Oncology Associates
Norfolk, Virginia, 23502, United States
Yakima Valley Mem Hosp/North Star Lodge
Yakima, Washington, 98902, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Craig Reynolds
- Organization
- Ocala Oncology, Ocala, FL, USA
Study Officials
- PRINCIPAL INVESTIGATOR
Craig H. Reynolds, MD
US Oncology Research, LLC; Ocala Oncology Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 18, 2009
First Posted
March 19, 2009
Study Start
February 1, 2009
Primary Completion
July 1, 2012
Study Completion
July 1, 2012
Last Updated
October 16, 2018
Results First Posted
October 16, 2018
Record last verified: 2018-10