Metastatic Renal Cell Carcinoma
Conditions
Brief summary
To evaluate the efficacy and safety of sunitinib in non-clear cell type renal cell carcinoma with the exception of pure sarcomatoid carcinoma and collecting duct carcinoma
Detailed description
There have been no standard treatment in non-clear cell renal cell carcinoma. Retrospective studies showed sunitinib or sorafenib might be active in non-clear cell renal cell carcinoma, especially papillary type and chromophobe type. This study is to evaluate efficacy and safety of sunitinib in this group of patients.
Interventions
DRUGSunitinib
Sunitinib 50 mg D1-D28 every 6 weeks
Sponsors
Samsung Medical Center
Seoul National University Hospital
Kyungpook National University Hospital
Asan Medical Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Histologically or cytologically confirmation of renal cell carcinoma without a clear cell histologic component, e.g., papillary type, chromophobe type, or collecting duct type 2. Patients with stage IV or recurrent disease not amenable to surgery, radiotherapy, or combined modality therapy with curative intent. 3. Measurable disease according to RECIST criteria 4. ECOG performance status 1 or better 5. Age 18 years or older 6. Adequate cardiac function 7. Adequate bone marrow, hepatic, and renal function 8. Life expectancy of ≥ 3 months 9. Singed and dated informed consent of document indicating that the patient (or legally acceptable representative) has been informed of all pertinent aspects of the trial prior to enrollment
Exclusion criteria
1. Clear cell type renal cell carcinoma or sarcomatoid carcinoma without any clue to the primary type 2. Diagnosis of any serious secondary malignancy within the last 2 years, except for adequately treated basal cell or squamous cell carcinoma of skin, or in situ carcinoma of cervix uteri 3. Hypertension that cannot be controlled by medications (blood pressure \> 150/90 mmHg despite optimal medical therapy) 4. Treatment with anticonvulsant agents and treatment with therapeutic doses of coumadin currently or within 2 weeks prior to first day of sunitinib administration. Low dose coumadin for DVT prophylaxis is permitted (up to 2 mg/day). 5. Pregnancy or breast feeding. 6. Other severe acute or chronic medical or psychiatric condition 7. Prior treatment on sunitinib, sorafenib, or bevacizumab.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Response rate | up to 12 months | Tumor response is to be measured every 6 weeks. RECIST v.1.1 will be used to definte target lesion and non-target lesion and classify the response category. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression free survival | up to 24 months | Form the date of enrollment to the date of the first documented disease progression or death from any cause, which came first. |
| overall survival | up to 36 months | — |
| Safety | up to 24 months | Safety will be assessed using CTCAE v.3.0 |
Countries
South Korea
Outcome results
None listed