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

NCT ID: NCT00570882

Last Updated: 2014-09-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-10-31
• Study Completion Date: 2014-06-30

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.

Conditions

Metastatic Renal Cell Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Sunitinib 4/2

Sunitinib 50 mg PO 4-week on and 2-week off

Group Type: ACTIVE_COMPARATOR

Sunitinib 4/2

Intervention Type: DRUG

Sunitinib 50 mg PO 4 weeks followed by 2 week rest

Sunitinib 2/1

Sunitinib 50 mg PO 2-week on 1-week off

Group Type: EXPERIMENTAL

Sunitinib 2/1

Intervention Type: DRUG

Sunitinib 50 mg PO 2 weeks followed by 1 week rest

Interventions

Sunitinib 2/1

Sunitinib 50 mg PO 2 weeks followed by 1 week rest

Intervention Type: DRUG

Sunitinib 4/2

Sunitinib 50 mg PO 4 weeks followed by 2 week rest

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Asan Medical Center

OTHER

Sponsor Role: lead

Responsible Party

JLee

Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jae-Lyun Lee, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

Locations

Daegu Catholic University Hospital

Daegu, , South Korea

Yeungnam University Medical Center

Daegu, , South Korea

Asan Medical Center

Seoul, , South Korea

Countries

South Korea

References

Lee JL, Kim MK, Park I, Ahn JH, Lee DH, Ryoo HM, Song C, Hong B, Hong JH, Ahn H. RandomizEd phase II trial of Sunitinib four weeks on and two weeks off versus Two weeks on and One week off in metastatic clear-cell type REnal cell carcinoma: RESTORE trial. Ann Oncol. 2015 Nov;26(11):2300-5. doi: 10.1093/annonc/mdv357. Epub 2015 Sep 7.

Reference Type: DERIVED

PMID: 26347107 (View on PubMed)

Other Identifiers

UOSG_AMC_0701

Identifier Type: -

Identifier Source: org_study_id