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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00570882

Enrollment

Registered

2007-12-11

Start date

2007-10-31

Completion date

2014-06-30

Last updated

2014-09-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic Renal Cell Carcinoma

Keywords

Renal cell carcinoma, Sunitinib, phase II study, Randomized study

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.

Interventions

DRUGSunitinib 2/1

Sunitinib 50 mg PO 2 weeks followed by 1 week rest

DRUGSunitinib 4/2

Sunitinib 50 mg PO 4 weeks followed by 2 week rest

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 15, 2026