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

Roswell Park Comprehensive Cancer Center

Status

Completed

Conditions

Kidney Cancer

Treatments

Procedure: therapeutic conventional surgery

Procedure: neoadjuvant therapy

Drug: sunitinib malate

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00849186

P30CA016056 (U.S. NIH Grant/Contract)

CDR0000634770

RPCI-I-95206

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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