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

Kidney Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00849186
• Other study ID #: CDR0000634770
• Secondary ID: P30CA016056RPCI-
• Status: Completed
• Phase: N/A
• First received: February 20, 2009
• Last updated: January 22, 2015
• Start date: August 2007
• Est. completion date: April 2010

Study information

• Verified date: January 2015
• Source: Roswell Park Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 2010
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Kidney Cancer
• Kidney Neoplasms

Intervention

Drug:
• sunitinib malate
oral

Procedure:
• neoadjuvant therapy
IV
• therapeutic conventional surgery
Surgery

Locations

Country	Name	City	State
United States	Roswell Park Cancer Institute	Buffalo	New York

Sponsors (2)

Lead Sponsor	Collaborator
Roswell Park Cancer Institute	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	90 days	Yes
Primary	Safety of Surgery After 90 Days of Treatment With SM	Incident Rate: Intraoperative Complication Rate	90 days	Yes
Secondary	Response Rate After 90 Days of Treatment With SM		90 days	No