Text Size

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

This study is currently recruiting participants.
Verified December 2011 by Asan Medical Center
Sponsor:
Information provided by (Responsible Party):
JLee, Asan Medical Center
ClinicalTrials.gov Identifier:
NCT00570882
First received: December 10, 2007
Last updated: December 5, 2011
Last verified: December 2011
History of Changes
  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
 Drug: Sunitinib 2/1
Drug: Sunitinib 4/2
 Phase 2

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Asan Medical Center:

Primary Outcome Measures:
  • Treatment failure rate (progressive disease, treatment withdrawal due to unacceptable toxicities, or any death) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    RECIST v.1.1 will be used to assess tumor responses

  • quality of life [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    EORTC QLQ C30 and EQ5D will be used to assess the quality of life

  • Progression free survival [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: about 12 months ] [ Designated as safety issue: Yes ]
    CTC AE v.3.0


Estimated Enrollment: 80
Study Start Date: October 2007
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Sunitinib 4/2
Sunitinib 50 mg PO 4-week on and 2-week off
 Drug: Sunitinib 4/2
Sunitinib 50 mg PO 4 weeks followed by 2 week rest
Experimental: Sunitinib 2/1
Sunitinib 50 mg PO 2-week on 1-week off
 Drug: Sunitinib 2/1
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:

  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.
  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
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            
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.            
Sponsors and Collaborators
Asan Medical Center
Investigators
Principal Investigator: Jae-Lyun Lee, MD, PhD Asan Medical Center
  More Information

No publications provided

Responsible Party: JLee, Associate professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT00570882     History of Changes
Other Study ID Numbers: UOSG_AMC_0701
Study First Received: December 10, 2007
Last Updated: December 5, 2011
Health Authority: Korea: Food and Drug Administration

Keywords provided by Asan Medical Center:
Renal cell carcinoma
Sunitinib
phase II study
Randomized study

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
 Urologic Diseases
Sunitinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on May 23, 2013