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

NCT ID: NCT00849186

Last Updated: 2015-02-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-08-31
• Study Completion Date: 2010-04-30

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.

Conditions

Kidney Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm 1

Group Type: EXPERIMENTAL

sunitinib malate

Intervention Type: DRUG

oral

neoadjuvant therapy

Intervention Type: PROCEDURE

IV

therapeutic conventional surgery

Intervention Type: PROCEDURE

Surgery

Interventions

sunitinib malate

oral

Intervention Type: DRUG

neoadjuvant therapy

IV

Intervention Type: PROCEDURE

therapeutic conventional surgery

Surgery

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Roswell Park Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Willie Underwood, MD

Role: PRINCIPAL_INVESTIGATOR

Roswell Park Cancer Institute

Locations

Roswell Park Cancer Institute

Buffalo, New York, United States

Countries

United States

Other Identifiers

P30CA016056

Identifier Type: NIH

Identifier Source: secondary_id

View Link

RPCI-I-95206

Identifier Type: -

Identifier Source: secondary_id

CDR0000634770

Identifier Type: -

Identifier Source: org_study_id