An interventional study of sunitinib malate and neoadjuvant therapy in Kidney Cancer, sponsored by Roswell Park Cancer Institute. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-02-06.
Sponsored by Roswell Park Cancer Institute · Not applicable, Interventional, and Treatment
RATIONALE: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving sunitinib before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
PURPOSE: This clinical trial is studying the side effects of giving sunitinib before surgery and to see how well it works in treating patients with localized or metastatic kidney cancer.
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients receive oral sunitinib malate once daily on days 1-90 in the absence of disease progression or unacceptable toxicity. Patients then undergo radical nephrectomy.
After completion of study treatment, patients are followed for 3 months.
956 studies on the registry are indexed under Kidney Neoplasms; 210 are open to participants now.
This study's enrollment of 20 is below the median of 43 across 650 interventional studies indexed under Kidney Neoplasms.
Browse Kidney Neoplasms studies →Roswell Park Cancer Institute is the lead sponsor of 412 studies on the registry; 62 are open to participants now.
Of its 38 completed or terminated interventional studies of FDA-regulated products, 21 (55%) have results posted.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
Newly diagnosed renal cell carcinoma
No history of or known spinal cord compression or carcinomatous meningitis OR evidence of symptomatic brain or leptomeningeal disease by CT scan or MRI
PATIENT CHARACTERISTICS:
No serious intercurrent illness including, but not limited to, any of the following:
None of the following conditions within the past 6 months:
PRIOR CONCURRENT THERAPY:
Drug: sunitinib malate · Procedure: neoadjuvant therapy · Procedure: therapeutic conventional surgery
oral
IV
Surgery
Safety of Sunitinib Malate (SM)
Incident Rate: The proportion of the population who experience a grade 3 or higher endpoint-relevant toxic event within 3 months of the beginning of treatment.
Time frame: 90 days
Safety of Surgery After 90 Days of Treatment With SM
Incident Rate: Intraoperative Complication Rate
Time frame: 90 days
Response Rate After 90 Days of Treatment With SM
Time frame: 90 days
| Milestone | Sunitinib Malate (Sunitinib) |
|---|---|
| Started | 26 |
| Completed | 16 |
| Not completed | 10 |
| Withdrew: Adverse event | 2 |
| Withdrew: Withdrawal by subject | 1 |
| Withdrew: Not treated | 6 |
| Withdrew: Other | 1 |
Incident Rate: The proportion of the population who experience a grade 3 or higher endpoint-relevant toxic event within 3 months of the beginning of treatment.
| proportion of participants | Sunitinib Malate (Sunitinib) |
|---|---|
| Safety of Sunitinib Malate (SM) | .350 (.1812 to .5671) |
Incident Rate: Intraoperative Complication Rate
| proportion of participants | Sunitinib Malate (Sunitinib) |
|---|---|
| Safety of Surgery After 90 Days of Treatment With SM | .150 (.0524 to .3604) |
| proportion of participants | Sunitinib |
|---|---|
| Response Rate After 90 Days of Treatment With SM | .20 (.0807 to .4160) |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Sunitinib | — | 0/20 (0%) | 20/20 (100%) |
| Event | Sunitinib |
|---|---|
| FatigueGeneral disorders | 12/20 |
| ThrombocytopeniaBlood and lymphatic system disorders | 8/20 |
| NauseaGastrointestinal disorders | 8/20 |
| Aspartate aminotransferase increasedInvestigations | 8/20 |
| LeukopeniaBlood and lymphatic system disorders | 7/20 |
| DiarrhoeaGastrointestinal disorders | 6/20 |
| DyspepsiaGastrointestinal disorders | 6/20 |
| Lipase increasedInvestigations | 6/20 |
| HypertensionVascular disorders | 5/20 |
| NeutropeniaBlood and lymphatic system disorders | 4/20 |
All treated and eligible patients
| Age, Continuous(years) | Sunitinib Malate (Sunitinib) |
|---|---|
| Mean | 60.24 ± 9.57 |
| Sex: Female, Male(Participants) | Sunitinib Malate (Sunitinib) |
|---|---|
| Female | 9 |
| Male | 11 |
This study is completed, as verified in Jan 2015. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Roswell Park Cancer Institute