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Kidney CancerPhase 2NCT01024205

Sunitinib Malate Before and After Surgery in Treating Patients With Previously Untreated Metastatic Kidney Cancer

A Phase 2 study testing sunitinib malate, laboratory biomarker analysis and adjuvant therapy in people with Kidney Cancer, run by Barts and the London School of Medicine and Dentistry at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Kidney Cancer
What is being tested?
sunitinib malate, laboratory biomarker analysis and adjuvant therapy
Type of treatment
Surgery or procedure
How many people
43 participants
Where
1 siteUnited Kingdom
Study dates
Aug 2007to May 2012
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

PATIENT CHARACTERISTICS:

  • 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

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)

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

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

    London, England, EC1M 6BQ

Other trials in United Kingdom

About this study

Official title: 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.

Read the detailed description

OBJECTIVES:

Primary

  • 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

  • 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.

Conditions
Kidney Cancer
Being tested
sunitinib malate, laboratory biomarker analysis, adjuvant therapy, neoadjuvant therapy, therapeutic conventional surgery
Keywords
clear cell renal cell carcinoma, stage IV renal cell cancer
Medical subject headings
Kidney Neoplasms, Carcinoma, Renal Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Neoadjuvant sunitinib malate achieving a clinical benefit of ≥ 70%

Secondary outcomes (3)

  1. Time to radiological progression

  2. Overall survival

  3. Proportion of patients suitable for nephrectomy after neoadjuvant sunitinib malate

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Dec 2009 (estimated)
  2. Study startAug 2007
  3. Primary completionAug 2010
  4. Study completionMay 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Masking
None (open label)
Enrolment
43 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01024205
Sponsor's protocol ID
OCTG-SuMR
Other IDs
CDR0000660317, EUDRACT-2006-004511-21, REDA-4911, MREC-07/Q0603/58, PFIZER-OCTG-SuMR
Status last verified
Jul 2011
First submitted
1 Dec 2009
Last updated
12 Aug 2013
Results posted
No

Publications

  • Powles T, Chowdhury S, Bower M, Saunders N, Lim L, Shamash J, Sarwar N, Sadev A, Peters J, Green J, Boleti K, Augwal S. The effect of sunitinib on immune subsets in metastatic clear cell renal cancer. Urol Int. 2011;86(1):53-9. doi: 10.1159/000319498. Epub 2010 Oct 26.

    PubMed 20975250

  • Stewart GD, Powles T, Van Neste C, Meynert A, O'Mahony F, Laird A, Deforce D, Van Nieuwerburgh F, Trooskens G, Van Criekinge W, De Meyer T, Harrison DJ. Dynamic epigenetic changes to VHL occur with sunitinib in metastatic clear cell renal cancer. Oncotarget. 2016 May 3;7(18):25241-50. doi: 10.18632/oncotarget.8308.

    PubMed 27029034

  • Stewart GD, O'Mahony FC, Laird A, Rashid S, Martin SA, Eory L, Lubbock AL, Nanda J, O'Donnell M, Mackay A, Mullen P, McNeill SA, Riddick AC, Aitchison M, Berney D, Bex A, Overton IM, Harrison DJ, Powles T. Carbonic anhydrase 9 expression increases with vascular endothelial growth factor-targeted therapy and is predictive of outcome in metastatic clear cell renal cancer. Eur Urol. 2014 Nov;66(5):956-63. doi: 10.1016/j.eururo.2014.04.007. Epub 2014 May 10.

    PubMed 24821582

  • Shaw GL, Hussain M, Nair R, Bycroft J, Beltran L, Green JS, Powles T, Peters JL. Performing cytoreductive nephrectomy following targeted sunitinib therapy for metastatic renal cell carcinoma: a surgical perspective. Urol Int. 2012;89(1):83-8. doi: 10.1159/000338057. Epub 2012 May 16.

    PubMed 22614181

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing sunitinib malate, laboratory biomarker analysis and adjuvant therapy in people with Kidney Cancer, run by Barts and the London School of Medicine and Dentistry at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Neoadjuvant sunitinib malate achieving a clinical benefit of ≥ 70%. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01024205, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2013; AzTrials last refreshed its copy on 6 Nov 2026.

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