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

A Pilot Study of Neoadjuvant SUNITINIB MALATE (Sunitinib) in Patients With Renal Cell Carcinoma Undergoing Nephrectomy

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00849186
Enrollment
20
Registered
2009-02-23
Start date
2007-08-31
Completion date
2010-04-30
Last updated
2015-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Cancer

Keywords

stage I renal cell cancer, stage II renal cell cancer, stage III renal cell cancer, stage IV renal cell cancer

Brief 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.

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.

Interventions

DRUGsunitinib malate

oral

PROCEDUREneoadjuvant therapy

IV

PROCEDUREtherapeutic conventional surgery

Surgery

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Roswell Park Cancer Institute
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion 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

Design outcomes

Primary

MeasureTime frameDescription
Safety of Sunitinib Malate (SM)90 daysIncident 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.
Safety of Surgery After 90 Days of Treatment With SM90 daysIncident Rate: Intraoperative Complication Rate

Secondary

MeasureTime frame
Response Rate After 90 Days of Treatment With SM90 days

Countries

United States

Participant flow

Participants by arm

ArmCount
Sunitinib Malate (Sunitinib)
sunitinib malate: 37.5 mg of daily oral sunitinib is given for 90 days prior to surgery neoadjuvant therapy: IV therapeutic conventional surgery: Surgery
20
Total20

Withdrawals & dropouts

PeriodReasonFG000
Overall StudyAdverse Event2
Overall Studynot treated6
Overall StudyOther1
Overall StudyWithdrawal by Subject1

Baseline characteristics

CharacteristicSunitinib Malate (Sunitinib)
Age, Continuous60.24 years
STANDARD_DEVIATION 9.57
Sex: Female, Male
Female
9 Participants
Sex: Female, Male
Male
11 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
20 / 20
serious
Total, serious adverse events
0 / 20

Outcome results

Primary

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

Population: All treated and eligible patients

ArmMeasureValue (NUMBER)
Sunitinib Malate (Sunitinib)Safety of Sunitinib Malate (SM).350 proportion of participants
Primary

Safety of Surgery After 90 Days of Treatment With SM

Incident Rate: Intraoperative Complication Rate

Time frame: 90 days

Population: All treated and eligible patients

ArmMeasureValue (NUMBER)
Sunitinib Malate (Sunitinib)Safety of Surgery After 90 Days of Treatment With SM.150 proportion of participants
Secondary

Response Rate After 90 Days of Treatment With SM

Time frame: 90 days

Population: All treated and eligible patients

ArmMeasureValue (NUMBER)
Sunitinib Malate (Sunitinib)Response Rate After 90 Days of Treatment With SM.20 proportion of participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026