Randomized Phase II Study of Sunitinib Administered as 4/2 vs. 2/1 Schedule in Advanced RCC - Full Text View

Sponsored by:	Asan Medical Center
Information provided by:	Asan Medical Center
ClinicalTrials.gov Identifier:	NCT00570882

Purpose

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.

Condition	Intervention	Phase
Metastatic Renal Cell Carcinoma, Clear Cell Type	Drug: Sunitinib 2/1 schedule Drug: Sunitinib 4/2 schedule	Phase II

Drug Information available for: Sunitinib Sunitinib malate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	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

Further study details as provided by Asan Medical Center:

Primary Outcome Measures:

Treatment failure rate (progressive diease, treatment withdrawal due to unacceptable toxicitieis, or any death) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Overall response, rate, adverse events grade 3 or worse, quality of life, progression-free survival, overall survival [ Time Frame: Not specified ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	72
Study Start Date:	October 2007
Estimated Study Completion Date:	October 2009

Arms	Assigned Interventions
1: Active Comparator Sunitinib 50 mg PO 4-week on and 2-week off	Drug: Sunitinib 4/2 schedule Sunitinib 50 mg PO 4 weeks followed by 2 week rest
2: Experimental Sunitinib 50 mg PO 2-week on 1-week off	Drug: Sunitinib 2/1 schedule Sunitinib 50 mg PO 2 weeks followed by 1 week rest

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00570882

Contacts

Contact: Kyung-Min Kim, BS	82-2-3010-5582	mk9765@amc.seoul.kr
Contact: Jae-Lyun Lee, MD, PhD	82-2-3010-5977	jaelyun@amc.seoul.kr

Locations

Korea, Republic of
Asan Medical Center	Recruiting
Seoul, Korea, Republic of, 138-736
Principal Investigator: Jae-Lyun Lee, MD, PhD.
Sub-Investigator: J-H Ahn, MD, PhD.
Sub-Investigator: D-H Lee, MD, PhD.
Sub-Investigator: H-J Ahn, MD, PhD
Sub-Investigator: C-S Kim, MD, PhD.
Sub-Investigator: C-R Song, MD.
Sub-Investigator: J-H Hong, MD, PhD.
Samsung Medical Center	Recruiting
Seoul, Korea, Republic of, 135-710
Contact: H-Y Lim, MD, PhD
Yonsei Cancer Center	Recruiting
Seoul, Korea, Republic of
Contact: S-Y Rha, MD, PhD.
Gyeongsang University Hospital	Recruiting
Jinju, Korea, Republic of
Contact: G-W Lee, MD, PhD.
Yeungnam University Medical Center	Recruiting
Daegu, Korea, Republic of
Contact: M-K Kim, MD, MSc.
Daegu Catholic University Hospital	Recruiting
Daegu, Korea, Republic of
Contact: S-H Bae
Korea, Republic of, Gyeonggido
Seoul National University Bundang Hospital	Recruiting
Seongnam, Gyeonggido, Korea, Republic of
Contact: J-H Kim, MD, PhD.

Sponsors and Collaborators

Asan Medical Center

Investigators

Principal Investigator:

Jae-Lyun Lee, MD, PhD

Asan Medical Center

More Information

Responsible Party:	Asan Medical Center ( Jae-Lyun Lee )
Study ID Numbers:	UOSG_AMC_0701
Study First Received:	December 10, 2007
Last Updated:	December 10, 2007
ClinicalTrials.gov Identifier:	NCT00570882
Health Authority:	Korea: Food and Drug Administration

Keywords provided by Asan Medical Center:

Renal cell carcinoma
Sunitinib
phase II study
Randomized study

Study placed in the following topic categories:

Urogenital Neoplasms
Renal cancer
Urologic Neoplasms
Kidney cancer
Carcinoma
Urologic Diseases
Kidney Neoplasms

Sunitinib
Carcinoma, Renal Cell
Kidney Diseases
Adenocarcinoma
Urinary tract neoplasm
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Antineoplastic Agents
Growth Substances
Therapeutic Uses

Physiological Effects of Drugs
Growth Inhibitors
Angiogenesis Modulating Agents
Angiogenesis Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 13, 2009