Sunitinib in Treating Patients With Locally Recurrent 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. Identifier: NCT00459875
Recruitment Status : Completed
First Posted : April 13, 2007
Results First Posted : November 26, 2015
Last Update Posted : November 26, 2015
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

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.

PURPOSE: This phase II trial is studying how well sunitinib works in treating patients with locally recurrent or metastatic kidney cancer.

Condition or disease Intervention/treatment Phase
Kidney Cancer Drug: sunitinib malate Phase 2

Detailed Description:



  • Determine the efficacy of sunitinib malate in patients with locally recurrent or metastatic papillary renal cell carcinoma.

OUTLINE: Patients receive oral sunitinib malate once daily on days 1-28. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed at 28 days and every 2 months thereafter.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Sunitinib in Patients With Metastatic Papillary Renal Cell Carcinoma
Study Start Date : March 2007
Actual Primary Completion Date : November 2010
Actual Study Completion Date : November 2010

Arm Intervention/treatment
Experimental: Sunitinib
The treatment will include Sunitinib malate 50 mg self-administered orally, once daily in the evening, without regard to meals, for 4 consecutive weeks (28 days) followed by 2 weeks (14 days) off, to comprise a complete cycle of 6 weeks.
Drug: sunitinib malate

Primary Outcome Measures :
  1. Overall Objective Response Rate as Measured by RECIST [ Time Frame: 2 years ]

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed advanced renal cell carcinoma of papillary or other non-clear cell histology

    • Metastatic or locally recurrent disease
  • Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral CT scan

    • The following are considered nonmeasurable disease:

      • Bone lesions
      • Ascites
      • Peritoneal carcinomatosis or miliary lesions
      • Pleural or pericardial effusions
      • Lymphangitis of the skin or lung
      • Cystic lesions
      • Irradiated lesions
  • Patients with primary tumor in place who are eligible for surgery must have undergone prior partial or radical nephrectomy
  • No history of or known brain metastases, spinal cord compression, or evidence of symptomatic brain or leptomeningeal carcinomatosis


  • Karnofsky performance status 70-100%
  • Absolute neutrophil count ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Hemoglobin ≥ 9.0 g/dL
  • Calcium ≤ 12.0 mg/dL
  • Creatinine ≤ 1.5 times upper limit of normal (ULN)
  • Bilirubin ≤ 1.5 times ULN
  • AST and ALT ≤ 2.5 times ULN (5 times ULN if liver function abnormalities are due to underlying malignancy)
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No hemorrhage ≥ grade 3 within the past 4 weeks
  • No diagnosis of any second malignancy within the past 5 years, except for adequately treated basal cell carcinoma, squamous cell skin cancer, or in situ cervical cancer
  • None of the following within the past 6 months:

    • Myocardial infarction
    • Severe or unstable angina
    • Coronary or peripheral artery bypass graft
    • Symptomatic congestive heart failure
    • Cerebrovascular accident or transient ischemic attack
    • Pulmonary embolism
  • No ongoing cardiac dysrhythmias ≥ grade 2 or atrial fibrillation of any grade
  • No prolongation of the QTc interval to > 450 msec (males) or > 470 msec (females)
  • No uncontrolled hypertension (i.e., blood pressure > 150/100 mm Hg despite optimal medical therapy)
  • No pre-existing thyroid abnormality, with thyroid function tests that cannot be maintained in the normal range with medication
  • No known HIV or AIDS-related illness
  • No other active infection
  • No other severe acute or chronic medical or psychiatric condition or laboratory abnormality that would preclude study compliance


  • See Disease Characteristics
  • No prior sunitinib malate
  • Prior or concurrent bisphosphonates allowed
  • More than 4 weeks since prior radiotherapy and recovered
  • Prior palliative radiotherapy to metastatic lesions allowed provided there is ≥ 1 measurable lesion that has not been irradiated
  • More than 4 weeks since prior major surgery and recovered
  • No concurrent therapeutic doses of warfarin

    • Low-dose warfarin ≤ 2 mg daily for thromboprophylaxis allowed
    • Concurrent low molecular weight heparin for full anticoagulation allowed
  • No other concurrent approved or investigational anticancer treatment, including chemotherapy, biological response modifiers, hormonal therapy, or immunotherapy
  • No other concurrent investigational drugs
  • No concurrent treatment on another clinical trial

    • Concurrent participation on supportive care trials or nontreatment trials (e.g., quality of life trials) allowed

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00459875

United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
National Cancer Institute (NCI)
Principal Investigator: Glenn Kroog, MD Memorial Sloan Kettering Cancer Center
Principal Investigator: Robert J. Motzer, MD Memorial Sloan Kettering Cancer Center

Publications of Results:
Responsible Party: Memorial Sloan Kettering Cancer Center Identifier: NCT00459875     History of Changes
Other Study ID Numbers: 07-019
P30CA008748 ( U.S. NIH Grant/Contract )
First Posted: April 13, 2007    Key Record Dates
Results First Posted: November 26, 2015
Last Update Posted: November 26, 2015
Last Verified: October 2015

Keywords provided by Memorial Sloan Kettering Cancer Center:
recurrent renal cell cancer
stage IV renal cell cancer

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