Non Small Cell Lung Cancer
Conditions
Keywords
Untreated NSCLC in patients > 70
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.
Interventions
DRUGSutent
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.
Sponsors
Pfizer
US Oncology Research
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
70 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease Control Rate (DCR) | Every 6 weeks until progressive disease or death due to any cause, up to 36 month. | 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
| Measure | Time frame | Description |
|---|---|---|
| Overall Response Rates (OR) | Every 6 weeks until progressive disease or death due to any causes, up to 36 months. | 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) | All patients were followed until progressive disease or death, up to 36 months. | 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. | All patients were followed until death or up to 36 months. | 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) | All patients were followed until progressive disease or death, up to 36 months. | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
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. | 63 |
| Total | 63 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 21 |
| Overall Study | Drug hold/delay more than 4 weeks | 1 |
| Overall Study | Hospitalized | 1 |
| Overall Study | Patient request | 11 |
Baseline characteristics
| Characteristic | Sunitinib Malate |
|---|---|
| Age, Continuous | 78.7 years STANDARD_DEVIATION 5.08 |
| Race/Ethnicity, Customized Black | 1 participants |
| Race/Ethnicity, Customized Caucasian | 60 participants |
| Race/Ethnicity, Customized Hispanic | 1 participants |
| Race/Ethnicity, Customized Other | 1 participants |
| Region of Enrollment United States | 63 participants |
| Sex: Female, Male Female | 31 Participants |
| Sex: Female, Male Male | 32 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 45 / 60 |
| serious Total, serious adverse events | 11 / 60 |
Outcome results
Primary
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.
Time frame: Every 6 weeks until progressive disease or death due to any cause, up to 36 month.
Population: Evaluable population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sunitinib Malate | Disease Control Rate (DCR) | 63.3 percentage of participants |
Secondary
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 frame: All patients were followed until death or up to 36 months.
Population: ITT population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sunitinib Malate | 1-year Overall Survival (OS) Rate. | 26 percentage of participants alive at 1yr |
Secondary
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.
Time frame: Every 6 weeks until progressive disease or death due to any causes, up to 36 months.
Population: Evaluable population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sunitinib Malate | Overall Response Rates (OR) | 6.7 percentage of participants |
Secondary
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.
Time frame: All patients were followed until progressive disease or death, up to 36 months.
Population: ITT population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Sunitinib Malate | Progression-free Survival (PFS) | 3.0 months |
Secondary
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.
Time frame: All patients were followed until progressive disease or death, up to 36 months.
Population: ITT population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Sunitinib Malate | Time to Progression (TTP) | 4.5 months |