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Upfront Sunitinib (SU011248) Therapy Followed by Surgery in Patients With Metastatic Renal Cancer: A Pilot Phase II Study [SuMR]

Phase 2
18 Years
Open (Enrolling)
Kidney Cancer

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Trial Information

Upfront Sunitinib (SU011248) Therapy Followed by Surgery in Patients With Metastatic Renal Cancer: A Pilot Phase II Study [SuMR]



- 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.

Inclusion Criteria


- 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

- 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)

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Neoadjuvant sunitinib malate achieving a clinical benefit of ≥ 70%

Safety Issue:


Principal Investigator

Thomas Powles, MD, MRCP

Investigator Role:

Principal Investigator

Investigator Affiliation:

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



Study ID:




Start Date:

August 2007

Completion Date:

Related Keywords:

  • Kidney Cancer
  • clear cell renal cell carcinoma
  • stage IV renal cell cancer
  • Carcinoma, Renal Cell
  • Kidney Neoplasms