Trial Of Sunitinib In Advanced Non-Clear Cell Type Renal Cell Carcinoma

Study Overview
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Brief Summary
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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
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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.

Official Title
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Phase II Trial Of Sunitinib In Advanced Non-Clear Cell Type Renal Cell Carcinoma

Conditions
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Metastatic Renal Cell Carcinoma

Intervention / Treatment
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* Drug: Sunitinib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically or cytologically confirmation of renal cell carcinoma without a clear cell histologic component, e.g., papillary type, chromophobe type, or collecting duct type Patients with stage IV or recurrent disease not amenable to surgery, radiotherapy, or combined modality therapy with curative intent. Measurable disease according to RECIST criteria ECOG performance status 1 or better Age 18 years or older Adequate cardiac function Adequate bone marrow, hepatic, and renal function Life expectancy of ≥ 3 months 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: Clear cell type renal cell carcinoma or sarcomatoid carcinoma without any clue to the primary type 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 Hypertension that cannot be controlled by medications (blood pressure > 150/90 mmHg despite optimal medical therapy) 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). Pregnancy or breast feeding. Other severe acute or chronic medical or psychiatric condition Prior treatment on sunitinib, sorafenib, or bevacizumab.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sunitinib<br>Sunitinib 50 mg D1-D28 every 6 weeks | Drug: Sunitinib<br>* Sunitinib 50 mg D1-D28 every 6 weeks<br>* Other names: Sutene;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate | 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. | up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival | Form the date of enrollment to the date of the first documented disease progression or death from any cause, which came first. | up to 24 months | 
| overall survival |  | up to 36 months | 
| Safety | Safety will be assessed using CTCAE v.3.0 | up to 24 months |