Back to resultsSunitinib Malate Before and After Surgery in Treating Patients With Previously Untreated Metastatic Kidney Cancer
Primary Purpose
Kidney Cancer
Status
Completed
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
sunitinib malate
laboratory biomarker analysis
adjuvant therapy
neoadjuvant therapy
therapeutic conventional surgery
Sponsored by
About this trial
This is an interventional treatment trial for Kidney Cancer focused on measuring clear cell renal cell carcinoma, stage IV renal cell cancer
Eligibility 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
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)
Sites / Locations
- Orchid Clinical Trials Group at Barts and the London School of Medicine and Dentistry
Outcomes
Primary Outcome Measures
Neoadjuvant sunitinib malate achieving a clinical benefit of ≥ 70%
Secondary Outcome Measures
Time to radiological progression
Overall survival
Proportion of patients suitable for nephrectomy after neoadjuvant sunitinib malate
Full Information
NCT ID
NCT01024205
First Posted
December 1, 2009
Last Updated
August 9, 2013
Sponsor
Barts and the London School of Medicine and Dentistry
1. Study Identification
Unique Protocol Identification Number
NCT01024205
Brief Title
Sunitinib Malate Before and After Surgery in Treating Patients With Previously Untreated Metastatic Kidney Cancer
Official Title
Upfront Sunitinib (SU011248) Therapy Followed by Surgery in Patients With Metastatic Renal Cancer: A Pilot Phase II Study [SuMR]
Study Type
Interventional
2. Study Status
Record Verification Date
July 2011
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
May 2012 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Barts and the London School of Medicine and Dentistry
4. Oversight
5. Study Description
Brief 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. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Cancer
Keywords
clear cell renal cell carcinoma, stage IV renal cell cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)
Enrollment
43 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
sunitinib malate
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Type
Procedure
Intervention Name(s)
adjuvant therapy
Intervention Type
Procedure
Intervention Name(s)
neoadjuvant therapy
Intervention Type
Procedure
Intervention Name(s)
therapeutic conventional surgery
Primary Outcome Measure Information:
Title
Neoadjuvant sunitinib malate achieving a clinical benefit of ≥ 70%
Secondary Outcome Measure Information:
Title
Time to radiological progression
Title
Overall survival
Title
Proportion of patients suitable for nephrectomy after neoadjuvant sunitinib malate
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Powles, MD, MRCP
Organizational Affiliation
Barts and the London School of Medicine and Dentistry
Official's Role
Principal Investigator
Facility Information:
Facility Name
Orchid Clinical Trials Group at Barts and the London School of Medicine and Dentistry
City
London
State/Province
England
ZIP/Postal Code
EC1M 6BQ
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
20975250
Citation
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.
Results Reference
result
PubMed Identifier
27029034
Citation
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.
Results Reference
derived
PubMed Identifier
24821582
Citation
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.
Results Reference
derived
PubMed Identifier
22614181
Citation
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.
Results Reference
derived
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Sunitinib Malate Before and After Surgery in Treating Patients With Previously Untreated Metastatic Kidney Cancer
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