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CompletedNCT00849186Updated Feb 6, 2015Results posted

Sunitinib and Surgery in Treating Patients With Localized or Metastatic Kidney Cancer

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

Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the detailed description

OBJECTIVES:

Primary

  • Determine the safety of sunitinib malate in patients with localized or metastatic renal cell carcinoma.
  • Determine the safety of surgery after 90 days of treatment with sunitinib malate in these patients.

Secondary

  • Determine response of these patients after 90 days of treatment with sunitinib malate.

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.

02

Conditions studied

  • Kidney Cancer

Keywords

  • stage I renal cell cancer
  • stage II renal cell cancer
  • stage III renal cell cancer
  • stage IV renal cell cancer
03

In context

Kidney Neoplasms

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 →

Lead sponsor

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.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

DISEASE CHARACTERISTICS:

  • Newly diagnosed renal cell carcinoma

    • Clinical stage T1b, T2, or T3 tumor with or without nodal or hematogenous metastasis
    • Localized or metastatic disease by renal biopsy
  • Primary tumor must be amenable to surgical removal
  • No history of or known spinal cord compression or carcinomatous meningitis OR evidence of symptomatic brain or leptomeningeal disease by CT scan or MRI

    • Treated, stable, and asymptomatic brain metastases are allowed

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-1
  • ANC ≥ 1,500/mm\^3
  • Platelets ≥ 100,000/mm\^3
  • Hemoglobin ≥ 9.0 g/dL
  • AST and ALT ≤ 2.5 times upper limit of normal (ULN) (≤ 5 times ULN if liver function abnormalities are due to underlying malignancy)
  • Total bilirubin ≤ 1.5 times ULN
  • Creatinine \< 2 mg/dL OR creatinine clearance > 40 mL/min
  • Calcium ≤ 10.2 mg/dL
  • QTc interval \< 500 msec
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective barrier contraception during and for 3 (male)-6 (female) months after completion of study treatment
  • No serious intercurrent illness including, but not limited to, any of the following:

    • Clinically significant cardiovascular disease (e.g., uncontrolled hypertension, myocardial infarction, unstable angina)
    • New York Heart Association ≥ class II congestive heart failure
    • Serious cardiac arrhythmia requiring medication
    • Peripheral vascular disease ≥ grade 2
    • Psychiatric illness/social situations that would limit compliance with study requirements
  • None of the following conditions within the past 6 months:

    • Myocardial infarction
    • Severe/unstable angina
    • Coronary/peripheral artery bypass graft
    • Symptomatic congestive heart failure
    • Cerebrovascular accident or transient ischemic attack
    • Pulmonary embolism
  • No ongoing cardiac dysrhythmias NCI CTCAE version 3.0 ≥ grade 2
  • No hypertension that cannot be controlled by medications (i.e., diastolic blood pressure > 100 mm Hg despite optimal medical therapy)
  • No known HIV positivity

PRIOR CONCURRENT THERAPY:

  • Not specified
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    Arm 1

    Drug: sunitinib malate · Procedure: neoadjuvant therapy · Procedure: therapeutic conventional surgery

Interventions

  • Drugsunitinib malate

    oral

  • Procedureneoadjuvant therapy

    IV

  • Proceduretherapeutic conventional surgery

    Surgery

06

What researchers measure

Primary outcomes

  1. 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

  2. Safety of Surgery After 90 Days of Treatment With SM

    Incident Rate: Intraoperative Complication Rate

    Time frame: 90 days

Secondary outcomes

  1. Response Rate After 90 Days of Treatment With SM

    Time frame: 90 days

07

Results

Posted Feb 6, 2015

Participant flow

Participant flow — Overall Study
MilestoneSunitinib Malate (Sunitinib)
Started26
Completed16
Not completed10
Withdrew: Adverse event2
Withdrew: Withdrawal by subject1
Withdrew: Not treated6
Withdrew: Other1

Outcome measures

PrimarySafety 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
Reported as:
Number · proportion of participants
Safety of Sunitinib Malate (SM)
proportion of participantsSunitinib Malate (Sunitinib)
Safety of Sunitinib Malate (SM).350 (.1812 to .5671)
PrimarySafety of Surgery After 90 Days of Treatment With SM

Incident Rate: Intraoperative Complication Rate

Time frame:
90 days
Reported as:
Number · proportion of participants
Safety of Surgery After 90 Days of Treatment With SM
proportion of participantsSunitinib Malate (Sunitinib)
Safety of Surgery After 90 Days of Treatment With SM.150 (.0524 to .3604)
SecondaryResponse Rate After 90 Days of Treatment With SM
Time frame:
90 days
Reported as:
Number · proportion of participants
Response Rate After 90 Days of Treatment With SM
proportion of participantsSunitinib
Response Rate After 90 Days of Treatment With SM.20 (.0807 to .4160)

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Sunitinib—0/20 (0%)20/20 (100%)
Most frequent other events
Showing 10 of 65
Most frequent other events
EventSunitinib
FatigueGeneral disorders12/20
ThrombocytopeniaBlood and lymphatic system disorders8/20
NauseaGastrointestinal disorders8/20
Aspartate aminotransferase increasedInvestigations8/20
LeukopeniaBlood and lymphatic system disorders7/20
DiarrhoeaGastrointestinal disorders6/20
DyspepsiaGastrointestinal disorders6/20
Lipase increasedInvestigations6/20
HypertensionVascular disorders5/20
NeutropeniaBlood and lymphatic system disorders4/20

Baseline characteristics

All treated and eligible patients

Age, Continuous
Age, Continuous(years)Sunitinib Malate (Sunitinib)
Mean60.24 ± 9.57
Sex: Female, Male
Sex: Female, Male(Participants)Sunitinib Malate (Sunitinib)
Female9
Male11
08

Study locations

1 site
  • Roswell Park Cancer Institute
    Buffalo, New York 14263-0001, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 6, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00849186
Lead sponsor
Roswell Park Cancer Institute
Collaborators
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Feb 23, 2009
Start date
Aug 2007
Primary completion
Jul 2009
Completion
Apr 2010
Results posted
Feb 6, 2015
Last update
Feb 6, 2015

Study contacts

Willie Underwood, MD
principal investigator · Roswell Park Cancer Institute

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2015. You cannot join it, but the record below documents what was studied.

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