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

Primary Purpose

Metastatic Renal Cell Carcinoma

Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Sunitinib 2/1
Sunitinib 4/2
Sponsored by
Asan Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Renal Cell Carcinoma focused on measuring Renal cell carcinoma, Sunitinib, phase II study, Randomized study

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Daegu Catholic University Hospital
  • Yeungnam University Medical Center
  • Asan Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Sunitinib 4/2

Sunitinib 2/1

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Overall response rate
RECIST v.1.1 will be used to assess tumor responses
quality of life
EORTC QLQ C30 and EQ5D will be used to assess the quality of life
Progression free survival
Overall survival
Adverse events
CTC AE v.3.0

Full Information

First Posted
December 10, 2007
Last Updated
September 22, 2014
Sponsor
Asan Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00570882
Brief Title
Study of Sunitinib Administered as 4/2 vs. 2/1 Schedule in Advanced Renal Cell Carcinoma (RCC)
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Asan Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Renal Cell Carcinoma
Keywords
Renal cell carcinoma, Sunitinib, phase II study, Randomized study

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
76 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sunitinib 4/2
Arm Type
Active Comparator
Arm Description
Sunitinib 50 mg PO 4-week on and 2-week off
Arm Title
Sunitinib 2/1
Arm Type
Experimental
Arm Description
Sunitinib 50 mg PO 2-week on 1-week off
Intervention Type
Drug
Intervention Name(s)
Sunitinib 2/1
Intervention Description
Sunitinib 50 mg PO 2 weeks followed by 1 week rest
Intervention Type
Drug
Intervention Name(s)
Sunitinib 4/2
Intervention Description
Sunitinib 50 mg PO 4 weeks followed by 2 week rest
Primary Outcome Measure Information:
Title
Treatment failure rate (progressive disease, treatment withdrawal due to unacceptable toxicities, or any death)
Description
From the date of randomization to the date of progressive disease, treatment withdrawal, or death from any cause, which came first.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Overall response rate
Description
RECIST v.1.1 will be used to assess tumor responses
Time Frame
6 months
Title
quality of life
Description
EORTC QLQ C30 and EQ5D will be used to assess the quality of life
Time Frame
12 months
Title
Progression free survival
Time Frame
12 months
Title
Overall survival
Time Frame
36 months
Title
Adverse events
Description
CTC AE v.3.0
Time Frame
about 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jae-Lyun Lee, MD, PhD
Organizational Affiliation
Asan Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Daegu Catholic University Hospital
City
Daegu
Country
Korea, Republic of
Facility Name
Yeungnam University Medical Center
City
Daegu
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
26347107
Citation
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.
Results Reference
derived

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

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