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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:
NCT00849186
First received: February 20, 2009
Last updated: September 21, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention
Kidney Cancer
Drug: sunitinib malate
Procedure: neoadjuvant therapy
Procedure: therapeutic conventional surgery

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Study of Neoadjuvant SUNITINIB MALATE (Sunitinib) in Patients With Renal Cell Carcinoma Undergoing Nephrectomy

Resource links provided by NLM:


Further study details as provided by Roswell Park Cancer Institute:

Primary Outcome Measures:
  • Safety of sunitinib malate (SM) [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
  • Safety of surgery after 90 days of treatment with SM [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Response rate after 90 days of treatment with SM [ Time Frame: 90 days ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: August 2007
Study Completion Date: April 2010
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: sunitinib malate
oral
Procedure: neoadjuvant therapy
IV
Procedure: therapeutic conventional surgery
Surgery

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00849186

Locations
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
Sponsors and Collaborators
Roswell Park Cancer Institute
Investigators
Principal Investigator: Willie Underwood, MD Roswell Park Cancer Institute
  More Information

Additional Information:
No publications provided

Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT00849186     History of Changes
Other Study ID Numbers: CDR0000634770, P30CA016056, RPCI-I-95206
Study First Received: February 20, 2009
Last Updated: September 21, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Roswell Park Cancer Institute:
stage I renal cell cancer
stage II renal cell cancer
stage III renal cell cancer
stage IV renal cell cancer

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Kidney Neoplasms
Adenocarcinoma
Carcinoma
Kidney Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Urogenital Neoplasms
Urologic Diseases
Urologic Neoplasms
Sunitinib
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Antineoplastic Agents
Growth Inhibitors
Growth Substances
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014