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

January 22, 2015 updated by: Roswell Park Cancer Institute

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1
Drug: sunitinib malate
oral
Procedure: neoadjuvant therapy
IV
Procedure: therapeutic conventional surgery
Surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety of Sunitinib Malate (SM)
Time Frame: 90 days
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
Safety of Surgery After 90 Days of Treatment With SM
Time Frame: 90 days
Incident Rate: Intraoperative Complication Rate
90 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Response Rate After 90 Days of Treatment With SM
Time Frame: 90 days
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Roswell Park Cancer Institute

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Willie Underwood, MD, Roswell Park Cancer Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2007

Primary Completion (Actual)

July 1, 2009

Study Completion (Actual)

April 1, 2010

Study Registration Dates

First Submitted

February 20, 2009

First Submitted That Met QC Criteria

February 20, 2009

First Posted (Estimate)

February 23, 2009

Study Record Updates

Last Update Posted (Estimate)

February 6, 2015

Last Update Submitted That Met QC Criteria

January 22, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000634770
  • P30CA016056 (U.S. NIH Grant/Contract)
  • RPCI-I-95206

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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