Sunitinib Either Before or After Cytoreductive Nephrectomy in Patients With Metastatic Renal Cell Carcinoma
18 Years
N/A
Both
Kidney Cancer
Trial Information
Sunitinib Either Before or After Cytoreductive Nephrectomy in Patients With Metastatic Renal Cell Carcinoma
OBJECTIVES:
Primary
- To compare the activity of sunitinib malate when administered before vs after
cytoreductive nephrectomy, in terms of response rate, in patients with metastatic renal
cell carcinoma.
- To compare the safety of these regimens in these patients.
Secondary
- To compare the time to progression in patients treated with these regimens.
- To compare the duration of response in patients treated with these regimens.
- To compare the overall survival of patients treated with these regimens.
OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients undergo cytoreductive nephrectomy. Patients then receive adjuvant
therapy comprising oral sunitinib malate once daily for 4 weeks. Treatment repeats
every 6 weeks for up to 1 year in the absence of disease progression or unacceptable
toxicity. Some patients may continue treatment beyond 1 year at the discretion of the
investigator.
- Arm II: Patients receive neoadjuvant therapy comprising oral sunitinib malate once
daily for 4 weeks. Treatment repeats every 6 weeks for 2 courses. After completion of
neoadjuvant therapy, patients undergo cytoreductive nephrectomy followed by adjuvant
sunitinib malate as in arm I.
After completion of study therapy, patients are followed every 2 months for up to 1 year.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Proven metastatic renal cell carcinoma
- Measurable disease (according to RECIST criteria)
- Eligible for cytoreductive nephrectomy
- Primary tumor is considered amenable to surgical extirpation by the attending
surgeon
- Thrombosis of the inferior vena cava below the epathic veins allowed
- No symptomatic brain metastases
PATIENT CHARACTERISTICS:
- ECOG performance status 0-1
- Adequate hematology and coagulation
- Amylase and lipase normal
- Adequate hepatic, renal, and cardiac function
- Not pregnant
- Negative pregnancy test
- No uncontrolled hypertension and/or clinically significant cardiovascular events or
disease within the past 12 months
- No other cancer within the past 5 years except adequately treated basal cell or
squamous cell skin cancer or carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
- No prior early nephrectomy due to clinical condition
- No prior systemic therapy for renal cell carcinoma (e.g., chemotherapy, hormonal
therapy, interferon, interleukin-2, lymphocyte-activated killer cells, or other
biological response modifiers)
- More than 12 days since prior potent CYP3A4 inducers, including any of the following:
- Rifampin
- Rifabutin
- Carbamazepine
- Phenobarbital
- Phenytoin
- St. John's wort
- Efavirenz
- Tipranavir
- More than 7 days since prior potent CYP3A4 inhibitors, including any of the
following:
- Ketoconazole
- Itraconazole
- Clarithromycin
- Erythromycin
- Diltiazem
- Verapamil
- Delavirdine
- Indinavir
- Saquinavir
- Ritonavir
- Atazanavir
- Nelfinavir
- No other concurrent approved or investigational anticancer treatment, including
chemotherapy, biological response modifiers, hormonal therapy, or immunotherapy
- No concurrent participation in any other treatment clinical trial
- No concurrent palliative radiotherapy or surgery
- No concurrent drugs with proarrhythmic potential, including any of the following:
- Terfenadine
- Quinidine
- Procainamide
- Disopyramide
- Sotalol
- Probucol
- Bepridil
- Haloperidol
- Risperidone
- Indapamide
- Flecainide
- Concurrent bisphosphonate therapy for metastatic bone disease allowed provided
therapy was initiated at least 4 weeks prior to the first dose of study drug
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Treatment
Outcome Measure:
Overall objective tumor response rate (complete response, partial response, stable disease, and progressive disease) as assessed by RECIST criteria
Safety Issue:
No
Principal Investigator
Marco Venturini, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Ospedale Sacro Cuore
Authority:
Unspecified
Study ID:
CDR0000588423
NCT ID:
NCT00626509
Start Date:
February 2008
Completion Date:
Related Keywords:
- Kidney Cancer
- stage IV renal cell cancer
- Carcinoma, Renal Cell
- Kidney Neoplasms
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