A Phase 2 interventional study of Sutent in Non Small Cell Lung Cancer, sponsored by US Oncology Research. Completed at 13 sites in United States. Open to participants aged 70 Years and older. Per ClinicalTrials.gov, last updated 2018-10-16.
Sponsored by US Oncology Research · Phase 2, Interventional, and Treatment
The purpose of this research study is to find out what effects (good and bad) sunitinib has on patients and their NSCLC.
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.
7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.
This study's enrollment of 63 is close to the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →US Oncology Research is the lead sponsor of 29 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Also known as: sunitinib malate
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.
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.
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.
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.
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.
| Milestone | Sunitinib Malate |
|---|---|
| Started | 63 |
| Completed | 29 |
| Not completed | 34 |
| Withdrew: Patient request | 11 |
| Withdrew: Hospitalized | 1 |
| Withdrew: Drug hold/delay more than 4 weeks | 1 |
| Withdrew: Adverse event | 21 |
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.
| percentage of participants | Sunitinib Malate |
|---|---|
| Disease Control Rate (DCR) | 63.3 (49.9 to 75.4) |
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.
| percentage of participants | Sunitinib Malate |
|---|---|
| Overall Response Rates (OR) | 6.7 (1.8 to 16.2) |
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.
| months | Sunitinib Malate |
|---|---|
| Progression-free Survival (PFS) | 3.0 (0.1 to 25.1) |
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.
| percentage of participants alive at 1yr | Sunitinib Malate |
|---|---|
| 1-year Overall Survival (OS) Rate. | 26 (16 to 38) |
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.
| months | Sunitinib Malate |
|---|---|
| Time to Progression (TTP) | 4.5 (0.1 to 25.1) |
Collected over During the whole treatment period, up to 30 days following last dose.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Sunitinib Malate | — | 11/60 (18.3%) | 45/60 (75%) |
| Event | Sunitinib Malate |
|---|---|
| DIARRHEAGastrointestinal disorders | 3/60 |
| THROMBOCYTOPENIABlood and lymphatic system disorders | 3/60 |
| APPETITE DECREASEDGastrointestinal disorders | 2/60 |
| DEHYDRATIONGastrointestinal disorders | 2/60 |
| FATIGUEGeneral disorders | 2/60 |
| ABDOMINAL PAINGastrointestinal disorders | 1/60 |
| ANEMIA HEMOLYTIC (NOS)Blood and lymphatic system disorders | 1/60 |
| BLEEDING GASTROINTESTINALGastrointestinal disorders | 1/60 |
| CARDIAC FAILURECardiac disorders | 1/60 |
| COLITIS ULCERATIVEGastrointestinal disorders | 1/60 |
| Event | Sunitinib Malate |
|---|---|
| FATIGUEGeneral disorders | 26/60 |
| DIARRHEAGastrointestinal disorders | 18/60 |
| THROMBOCYTOPENIABlood and lymphatic system disorders | 16/60 |
| MUCOSITISInfections and infestations | 14/60 |
| NAUSEAGastrointestinal disorders | 14/60 |
| ANOREXIAGastrointestinal disorders | 13/60 |
| NEUTROPENIABlood and lymphatic system disorders | 9/60 |
| CONSTIPATIONGastrointestinal disorders | 8/60 |
| DYSGUESIAGastrointestinal disorders | 8/60 |
| VOMITINGGastrointestinal disorders | 8/60 |
ITT population
| Age, Continuous(years) | Sunitinib Malate |
|---|---|
| Mean | 78.7 ± 5.08 |
| Sex: Female, Male(Participants) | Sunitinib Malate |
|---|---|
| Female | 31 |
| Male | 32 |
| Race/Ethnicity, Customized(participants) | Sunitinib Malate |
|---|---|
| Caucasian | 60 |
| Black | 1 |
| Hispanic | 1 |
| Other | 1 |
| Region of Enrollment(participants) | Sunitinib Malate |
|---|---|
| United States | 63 |
This study is completed, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.
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