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

Metastatic Renal Cell Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00570882
• Other study ID #: UOSG_AMC_0701
• Status: Completed
• Phase: Phase 2
• First received: December 10, 2007
• Last updated: September 22, 2014
• Start date: October 2007
• Est. completion date: June 2014

Study information

• Verified date: September 2014
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Metastatic Renal Cell Carcinoma

Intervention

Drug:
• Sunitinib 2/1
Sunitinib 50 mg PO 2 weeks followed by 1 week rest
• Sunitinib 4/2
Sunitinib 50 mg PO 4 weeks followed by 2 week rest

Locations

Country	Name	City	State
Korea, Republic of	Daegu Catholic University Hospital	Daegu
Korea, Republic of	Yeungnam University Medical Center	Daegu
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment failure rate (progressive disease, treatment withdrawal due to unacceptable toxicities, or any death)	From the date of randomization to the date of progressive disease, treatment withdrawal, or death from any cause, which came first.	12 months	Yes
Secondary	Overall response rate	RECIST v.1.1 will be used to assess tumor responses	6 months	No
Secondary	quality of life	EORTC QLQ C30 and EQ5D will be used to assess the quality of life	12 months	No
Secondary	Progression free survival		12 months	No
Secondary	Overall survival		36 months	No
Secondary	Adverse events	CTC AE v.3.0	about 12 months	Yes