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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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ClinicalTrials.gov Identifier: NCT00570882
Recruitment Status : Completed
First Posted : December 11, 2007
Last Update Posted : September 25, 2014
Information provided by (Responsible Party):
JLee, Asan Medical Center

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.

Condition or disease Intervention/treatment Phase
Metastatic Renal Cell Carcinoma Drug: Sunitinib 2/1 Drug: Sunitinib 4/2 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : October 2007
Primary Completion Date : June 2014
Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Treatment failure rate (progressive disease, treatment withdrawal due to unacceptable toxicities, or any death) [ Time Frame: 12 months ]
    From the date of randomization to the date of progressive disease, treatment withdrawal, or death from any cause, which came first.

Secondary Outcome Measures :
  1. Overall response rate [ Time Frame: 6 months ]
    RECIST v.1.1 will be used to assess tumor responses

  2. quality of life [ Time Frame: 12 months ]
    EORTC QLQ C30 and EQ5D will be used to assess the quality of life

  3. Progression free survival [ Time Frame: 12 months ]
  4. Overall survival [ Time Frame: 36 months ]
  5. Adverse events [ Time Frame: about 12 months ]
    CTC AE v.3.0

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00570882

Korea, Republic of
Daegu Catholic University Hospital
Daegu, Korea, Republic of
Yeungnam University Medical Center
Daegu, Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of, 138-736
Sponsors and Collaborators
Asan Medical Center
Principal Investigator: Jae-Lyun Lee, MD, PhD Asan Medical Center

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: JLee, Associate professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT00570882     History of Changes
Other Study ID Numbers: UOSG_AMC_0701
First Posted: December 11, 2007    Key Record Dates
Last Update Posted: September 25, 2014
Last Verified: September 2014

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

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