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

Phase 2

Completed

• Conditions: Metastatic Renal Cell Carcinoma
• Interventions: Drug: Sunitinib 4/2; Drug: Sunitinib 2/1

• Registration Number: NCT00570882
• Lead Sponsor: Asan Medical Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2007-12-10
• Study First Submitted QC: 2007-12-10
• Study First Posted: 2007-12-11
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-22
• Last Update Posted: 2014-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 76

Inclusion Criteria

1. Histologically or cytologically confirmation of renal cell carcinoma with a clear cell histologic component
2. Patients must present with stage IV disease not amenable to surgery, radiotherapy, or combined modality therapy with curative intent.
3. Measurable disease according to RECIST criteria are required but patients with evaluable lesions without measurable lesions are allowed to be enrolled to this study
4. ECOG performance status 2 or better
5. Age 18 years or older
6. Adequate bone marrow, hepatic, and renal function
7. Life expectancy of > 3 months
8. 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. Known spinal cord compression or carcinomatous meningitis
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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sunitinib 4/2	Sunitinib 4/2	Sunitinib 50 mg PO 4-week on and 2-week off
Sunitinib 2/1	Sunitinib 2/1	Sunitinib 50 mg PO 2-week on 1-week off

Primary Outcome Measures

Name	Time	Method
Treatment failure rate (progressive disease, treatment withdrawal due to unacceptable toxicities, or any death)	12 months	From the date of randomization to the date of progressive disease, treatment withdrawal, or death from any cause, which came first.

Secondary Outcome Measures

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

Trial Locations

Locations (3)

Yeungnam University Medical Center; 🇰🇷 Daegu, Korea, Republic of

Daegu Catholic University Hospital; 🇰🇷 Daegu, Korea, Republic of

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of