Sunitinib Malate Before and After Surgery in Treating Patients With Previously Untreated 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: NCT01024205
Recruitment Status : Completed
First Posted : December 2, 2009
Last Update Posted : August 12, 2013
Information provided by:
National Cancer Institute (NCI)

December 1, 2009
December 2, 2009
August 12, 2013
August 2007
August 2010   (Final data collection date for primary outcome measure)
Neoadjuvant sunitinib malate achieving a clinical benefit of ≥ 70%
Same as current
Complete list of historical versions of study NCT01024205 on Archive Site
  • Time to radiological progression
  • Overall survival
  • Proportion of patients suitable for nephrectomy after neoadjuvant sunitinib malate
Same as current
Not Provided
Not Provided
Sunitinib Malate Before and After Surgery in Treating Patients With Previously Untreated Metastatic Kidney Cancer
Upfront Sunitinib (SU011248) Therapy Followed by Surgery in Patients With Metastatic Renal Cancer: A Pilot Phase II Study [SuMR]

RATIONALE: Sunitinib malate 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 malate before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving sunitinib malate after surgery may kill any tumor cells that remain after surgery.

PURPOSE: This phase II trial is studying how well giving sunitinib malate before and after surgery works in treating patients with metastatic kidney cancer.



  • Determine if neoadjuvant sunitinib malate can achieve a clinical benefit of 70% or more to the primary renal tumor prior to surgery and adjuvant sunitinib malate in patients with metastatic renal cancer.


  • Determine the time to radiological progression in these patients.
  • Determine the overall survival of these patients.
  • Determine the proportion of patients suitable for nephrectomy after neoadjuvant sunitinib malate.
  • Determine the translational endpoints.

OUTLINE: Patients receive oral sunitinib malate once daily on days 1-28. Treatment repeats every 6 weeks for 3 courses. Approximately 2 weeks later, patients undergo a standard radical nephrectomy with lymph node dissection. Beginning at least 2 weeks after surgery, patients receive oral sunitinib malate on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.

Blood and tissue samples may be collected periodically for laboratory studies.

After completion of study treatment, patients are followed every 2 months.

Phase 2
Masking: None (Open Label)
Primary Purpose: Treatment
Kidney Cancer
  • Drug: sunitinib malate
  • Other: laboratory biomarker analysis
  • Procedure: adjuvant therapy
  • Procedure: neoadjuvant therapy
  • Procedure: therapeutic conventional surgery
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
May 2012
August 2010   (Final data collection date for primary outcome measure)


  • Histologically confirmed renal cell carcinoma

    • Measurable metastatic disease on CT/MRI imaging
    • Patients with suspicion of renal cancer on radiology must have a biopsy to confirm diagnosis of clear cell disease
  • No prior therapy for renal cancer
  • Judged by the treating physician to have the potential to derive clinical benefit from this treatment


  • ECOG performance status 0-2
  • Absolute neutrophil count ≥ 1 x 10^9/L (without growth factor support)
  • Platelet count ≥ 75 x 10^9/L
  • Total bilirubin ≤ 2 times upper limit of normal (ULN) (except for patients with Gilbert disease)
  • Serum creatinine ≤ 2 times ULN
  • Serum transaminases < 5 times ULN
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for ≥ 28 days after completion of study therapy
  • Willing and able to comply with scheduled visits, treatment plan, and laboratory tests and other study procedures
  • No congestive heart failure, myocardial infarction, or coronary artery bypass graft within the past 6 months, or ongoing severe or unstable arrhythmia requiring medication
  • No other severe acute or chronic medical or psychiatric condition, or abnormal laboratory results that would impart, in the judgement of the investigator, excess risk associated with study participation or study drug administration or would make the patient inappropriate for entry into this study


  • See Disease Characteristics
  • At least 7 days since prior and no concurrent potent CYP3A inhibitors, including any of the following:

    • Ketoconazole
    • Itraconazole
    • Clarithromycin
    • Erythromycin
    • Diltiazem
    • Verapamil
    • Delavirdine
    • Indinavir
    • Saquinavir
    • Ritonavir
    • Atazanavir
    • Nelfinavir
  • At least 12 days since prior and no concurrent potent CYP3A inducers, including any of the following:

    • Rifampin
    • Rifabutin
    • Carbamazepine
    • Phenobarbital
    • Phenytoin
    • St. John's wort
    • Efavirenz
    • Tipranavir
  • Concurrent radiotherapy allowed provided sunitinib malate is stopped one day before and resumed one day after radiotherapy
  • Concurrent coumarin-derivative anticoagulants (e.g., warfarin) allowed (≤ 2 mg/day) for prophylaxis of thrombosis
  • No concurrent treatment with a drug having proarrhythmic potential (i.e., terfenadine, quinidine, procainamide, disopyramide, sotalol, probucol, bepridil, haloperidol, risperidone, indapamide, or flecainide)
  • No other concurrent investigational drug or participation in another clinical trial (unless approved by the sponsor)
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United Kingdom
CDR0000660317 ( Registry Identifier: PDQ (Physician Data Query) )
Not Provided
Not Provided
Not Provided
Not Provided
Barts and the London School of Medicine and Dentistry
Not Provided
Principal Investigator: Thomas Powles, MD, MRCP Barts and the London School of Medicine and Dentistry
National Cancer Institute (NCI)
July 2011

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