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Sunitinib Non Small Cell Lung Cancer Patients Over 70

Primary Purpose

Non Small Cell Lung Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Sutent
Sponsored by
US Oncology Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non Small Cell Lung Cancer focused on measuring Untreated NSCLC in patients > 70

Eligibility Criteria

70 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ocala Oncology Center
  • Cancer Centers of Florida, P.A.
  • Minnesota Oncology Hematology, P.A.
  • Cancer Centers of North Carolina
  • Willamette Valley Cancer Institute and Research Center
  • Cancer Centers of the Carolinas
  • Texas Oncology - Arlington South
  • Texas Oncology, P.A. - Bedford
  • Methodist Charlton Cancer Ctr.
  • Texas Cancer Center of Mesquite
  • Texas Oncology Cancer Care and Research Center
  • Virginia Oncology Associates
  • Yakima Valley Mem Hosp/North Star Lodge

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Sunitinib Malate

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
March 18, 2009
Last Updated
October 12, 2018
Sponsor
US Oncology Research
Collaborators
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00864721
Brief Title
Sunitinib Non Small Cell Lung Cancer Patients Over 70
Official Title
Phase II Trial of Sunitinib Malate in Previously Untreated NSCLC Patients Over the Age of 70
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
US Oncology Research
Collaborators
Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Small Cell Lung Cancer
Keywords
Untreated NSCLC in patients > 70

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
63 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sunitinib Malate
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Sutent
Other Intervention Name(s)
sunitinib malate
Intervention Description
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.
Primary Outcome Measure Information:
Title
Disease Control Rate (DCR)
Description
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.
Time Frame
Every 6 weeks until progressive disease or death due to any cause, up to 36 month.
Secondary Outcome Measure Information:
Title
Overall Response Rates (OR)
Description
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.
Time Frame
Every 6 weeks until progressive disease or death due to any causes, up to 36 months.
Title
Progression-free Survival (PFS)
Description
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.
Time Frame
All patients were followed until progressive disease or death, up to 36 months.
Title
1-year Overall Survival (OS) Rate.
Description
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.
Time Frame
All patients were followed until death or up to 36 months.
Title
Time to Progression (TTP)
Description
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.
Time Frame
All patients were followed until progressive disease or death, up to 36 months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Craig H. Reynolds, MD
Organizational Affiliation
US Oncology Research, LLC; Ocala Oncology Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ocala Oncology Center
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
Facility Name
Cancer Centers of Florida, P.A.
City
Ocoee
State/Province
Florida
ZIP/Postal Code
34761
Country
United States
Facility Name
Minnesota Oncology Hematology, P.A.
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States
Facility Name
Cancer Centers of North Carolina
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
Willamette Valley Cancer Institute and Research Center
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401-8122
Country
United States
Facility Name
Cancer Centers of the Carolinas
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Facility Name
Texas Oncology - Arlington South
City
Arlington
State/Province
Texas
ZIP/Postal Code
76014
Country
United States
Facility Name
Texas Oncology, P.A. - Bedford
City
Bedford
State/Province
Texas
ZIP/Postal Code
76022
Country
United States
Facility Name
Methodist Charlton Cancer Ctr.
City
Dallas
State/Province
Texas
ZIP/Postal Code
75237
Country
United States
Facility Name
Texas Cancer Center of Mesquite
City
Mesquite
State/Province
Texas
ZIP/Postal Code
75150
Country
United States
Facility Name
Texas Oncology Cancer Care and Research Center
City
Waco
State/Province
Texas
ZIP/Postal Code
76712
Country
United States
Facility Name
Virginia Oncology Associates
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Yakima Valley Mem Hosp/North Star Lodge
City
Yakima
State/Province
Washington
ZIP/Postal Code
98902
Country
United States

12. IPD Sharing Statement

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Sunitinib Non Small Cell Lung Cancer Patients Over 70

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