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Clinical Trials (PDQ®)

  • First Published: 11/30/2009
  • Last Modified: 7/28/2011

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Clinical Trials (PDQ®)

Phase II Pilot Study of Neoadjuvant Sunitinib Malate Followed by Surgery and Adjuvant Sunitinib Malate in Patients With Previously Untreated Metastatic Renal Cancer. Note: The information about this trial has not been updated by the sponsor/principal investigator/lead organization. Cancer.gov cannot verify the accuracy of the information.

Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

Sunitinib Malate Before and After Surgery in Treating Patients With Previously Untreated Metastatic Kidney Cancer. Note: The information about this trial has not been updated by the sponsor/principal investigator/lead organization. Cancer.gov cannot verify the accuracy of the information.

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIBiomarker/Laboratory analysis, TreatmentUnknown18 and overOther, Pharmaceutical / IndustryOCTG-SuMR
2006-004511-21, EUDRACT-2006-004511-21, REDA-4911, MREC-07/Q0603/58, PFIZER-OCTG-SuMR, NCT01024205

Objectives

Primary

  1. 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.

Secondary

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

Entry Criteria

Disease Characteristics:

  • 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

Prior/Concurrent Therapy:

  • 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)

Patient Characteristics:

  • ECOG performance status 0-2
  • Absolute neutrophil count ≥ 1 x 109/L (without growth factor support)
  • Platelet count ≥ 75 x 109/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

Expected Enrollment

43

Outcomes

Primary Outcome(s)

Neoadjuvant sunitinib malate achieving a clinical benefit of ≥ 70%

Secondary Outcome(s)

Time to radiological progression
Overall survival
Proportion of patients suitable for nephrectomy after neoadjuvant sunitinib malate

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.

Published Results

Powles T, Chowdhury S, Bower M, et al.: The effect of sunitinib on immune subsets in metastatic clear cell renal cancer. Urol Int 86 (1): 53-9, 2011.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Orchid Clinical Trials Group at Barts and the London School of Medicine and Dentistry

Thomas Powles, MD, MRCP, Principal investigator
Ph: 44-207-882-8761

Registry Information
Official Title Upfront Sunitinib (SU011248) Therapy Followed by Surgery in Patients with Metastatic Renal Cancer: A Pilot Phase II Study [SuMR]
Trial Start Date 2007-08-01
Trial Completion Date 2010-08-01 (estimated)
Registered in ClinicalTrials.gov NCT01024205
Date Submitted to PDQ 2009-11-20
Information Last Verified 2011-07-28

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.

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