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

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

Study Overview

• Status: Completed
• Conditions: Non Small Cell Lung Cancer
• Intervention / Treatment: Drug: Sutent

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
• Enrollment (Actual): 63
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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 Names: sunitinib malate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Response Rates (OR)	Overall response rates = CR + PR. 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; Overall Response (OR) = CR + PR.	Every 6 weeks until progressive disease or death due to any causes, up to 36 months.
Progression-free Survival (PFS)	PFS is measured from the date of registration to the date of first documented disease progression or date of death, whichever comes first. If a patient neither progresses nor dies, this patient will be censored at the date of last contact. Progressive disease (PD) is defined as appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.	All patients were followed until progressive disease or death, up to 36 months.
1-year Overall Survival (OS) Rate.	OS is measured from the date of registration to the date of death for a dead patient. If a patient is still alive or is lost to follow up, the patient will be censored at the date of last contact.	All patients were followed until death or up to 36 months.
Time to Progression (TTP)	TTP is measured from the date of registration to the date of first documented disease progression or date of death due to progressive disease, whichever comes first. If a patient neither progresses nor dies due to progressive disease, this patient will be censored at the date of last contact. Progressive disease is defined as appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.	All patients were followed until progressive disease or death, up to 36 months.

Collaborators and Investigators

• Sponsor: US Oncology Research
• Collaborators: Pfizer
• Investigators: Principal Investigator: Craig H. Reynolds, MD, US Oncology Research, LLC; Ocala Oncology Center

Study record dates

Study Major Dates

• Study Start: February 1, 2009
• Primary Completion (ACTUAL): July 1, 2012
• Study Completion (ACTUAL): July 1, 2012

Study Registration Dates

• First Submitted: March 18, 2009
• First Submitted That Met QC Criteria: March 18, 2009
• First Posted (ESTIMATE): March 19, 2009

Study Record Updates

• Last Update Posted (ACTUAL): October 16, 2018
• Last Update Submitted That Met QC Criteria: October 12, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: Untreated NSCLC in patients > 70
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Protein Kinase Inhibitors; Sunitinib
• Other Study ID Numbers: 06-135; GA6181UU (OTHER: Pfizer)