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Trial Title:
Sunitinib Before or After Surgery in Treating Patients With Metastatic Kidney Cancer
NCT ID:
NCT00626509
Condition:
Kidney Cancer
Conditions: Official terms:
Kidney Neoplasms
Carcinoma, Renal Cell
Sunitinib
Conditions: Keywords:
stage IV renal cell cancer
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Primary purpose:
Treatment
Intervention:
Intervention type:
Drug
Intervention name:
sunitinib malate
Intervention type:
Procedure
Intervention name:
adjuvant therapy
Intervention type:
Procedure
Intervention name:
neoadjuvant therapy
Intervention type:
Procedure
Intervention name:
therapeutic conventional surgery
Summary:
RATIONALE: Sunitinib 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 before
surgery may make the tumor smaller and reduce the amount of normal tissue that needs to
be removed. Giving it after surgery may kill any tumor cells that remain after surgery.
It is not yet known whether sunitinib is more effective when given before or after
surgery in treating kidney cancer.
PURPOSE: This randomized phase II trial is studying the side effects of sunitinib and to
compare how well it works when given before or after surgery in treating patients with
metastatic kidney cancer.
Detailed description:
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.
Criteria for eligibility:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Ospedale Sacro Cuore
Address:
City:
Negrar
Zip:
37024
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Contact Person
Phone:
39-045-601-3912
Start date:
February 2008
Lead sponsor:
Agency:
Gruppo Italiano Carcinoma Renale
Agency class:
Other
Source:
National Cancer Institute (NCI)
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT00626509