Overview

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

Status:
Completed

Trial end date:
2014-06-01

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Asan Medical Center

Treatments:

Sunitinib

Criteria

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.