Study of Sunitinib Administered as 4/2 vs. 2/1 Schedule in Advanced Renal Cell Carcinoma (RCC)

Study Overview
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Brief Summary
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This study is to evaluate the efficacy, safety, and feasibility of sunitinib in 4/2 and 2/1 regimen in previously untreated metastatic RCC to select the most promising regimen, which should be used in further studies of this patient population.

Official Title
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A Randomized Phase II Trial Of Sunitinib Administered Daily For 4 Weeks, Followed By 2-Week Rest Vs. 2-Week On And 1-Week Off In Metastatic Renal Cell Carcinoma

Conditions
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Metastatic Renal Cell Carcinoma

Intervention / Treatment
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* Drug: Sunitinib 2/1
* Drug: Sunitinib 4/2


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically or cytologically confirmation of renal cell carcinoma with a clear cell histologic component Patients must present with stage IV disease not amenable to surgery, radiotherapy, or combined modality therapy with curative intent. Measurable disease according to RECIST criteria are required but patients with evaluable lesions without measurable lesions are allowed to be enrolled to this study ECOG performance status 2 or better Age 18 years or older 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: Known spinal cord compression or carcinomatous meningitis 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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Sunitinib 4/2<br>Sunitinib 50 mg PO 4-week on and 2-week off | Drug: Sunitinib 4/2<br>* Sunitinib 50 mg PO 4 weeks followed by 2 week rest<br>|
| Experimental: Sunitinib 2/1<br>Sunitinib 50 mg PO 2-week on 1-week off | Drug: Sunitinib 2/1<br>* Sunitinib 50 mg PO 2 weeks followed by 1 week rest<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment failure rate (progressive disease, treatment withdrawal due to unacceptable toxicities, or any death) | From the date of randomization to the date of progressive disease, treatment withdrawal, or death from any cause, which came first. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall response rate | RECIST v.1.1 will be used to assess tumor responses | 6 months | 
| quality of life | EORTC QLQ C30 and EQ5D will be used to assess the quality of life | 12 months | 
| Progression free survival |  | 12 months | 
| Overall survival |  | 36 months | 
| Adverse events | CTC AE v.3.0 | about 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Renal cell carcinoma, Sunitinib, phase II study, Randomized study