Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00849186
Recruitment Status : Completed
First Posted : February 23, 2009
Results First Posted : February 6, 2015
Last Update Posted : February 6, 2015
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Roswell Park Cancer Institute

Tracking Information
First Submitted Date  ICMJE February 20, 2009
First Posted Date  ICMJE February 23, 2009
Results First Submitted Date  ICMJE January 22, 2015
Results First Posted Date  ICMJE February 6, 2015
Last Update Posted Date February 6, 2015
Study Start Date  ICMJE August 2007
Actual Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 22, 2015)
  • 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.
  • Safety of Surgery After 90 Days of Treatment With SM [ Time Frame: 90 days ]
    Incident Rate: Intraoperative Complication Rate
Original Primary Outcome Measures  ICMJE
 (submitted: February 20, 2009)
  • Safety of Sunitinib Malate (SM)
  • Safety of Surgery After 90 Days of Treatment With SM
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 20, 2011)
Response Rate After 90 Days of Treatment With SM [ Time Frame: 90 days ]
Original Secondary Outcome Measures  ICMJE
 (submitted: February 20, 2009)
  • Response Rate After 90 Days of Treatment With SM
  • Progression-free survival after treatment with SM and radical nephrectomy
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Sunitinib and Surgery in Treating Patients With Localized or Metastatic Kidney Cancer
Official Title  ICMJE A Pilot Study of Neoadjuvant SUNITINIB MALATE (Sunitinib) in Patients With Renal Cell Carcinoma Undergoing Nephrectomy
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Kidney Cancer
Intervention  ICMJE
  • Drug: sunitinib malate
    oral
  • Procedure: neoadjuvant therapy
    IV
  • Procedure: therapeutic conventional surgery
    Surgery
Study Arms  ICMJE Experimental: Arm 1
Interventions:
  • Drug: sunitinib malate
  • Procedure: neoadjuvant therapy
  • Procedure: therapeutic conventional surgery
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 20, 2009)
20
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2010
Actual Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00849186
Other Study ID Numbers  ICMJE CDR0000634770
P30CA016056 ( U.S. NIH Grant/Contract )
RPCI-I-95206
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Roswell Park Cancer Institute
Study Sponsor  ICMJE Roswell Park Cancer Institute
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Willie Underwood, MD Roswell Park Cancer Institute
PRS Account Roswell Park Cancer Institute
Verification Date January 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP