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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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Metastatic Renal Cell Carcinoma

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Treatment failure rate (progressive disease, treatment withdrawal due to unacceptable toxicities, or any death)

Outcome Description:

From the date of randomization to the date of progressive disease, treatment withdrawal, or death from any cause, which came first.

Outcome Time Frame:

12 months

Safety Issue:

Yes

Principal Investigator

Jae-Lyun Lee, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Asan Medical Center

Authority:

Korea: Food and Drug Administration

Study ID:

UOSG_AMC_0701

NCT ID:

NCT00570882

Start Date:

October 2007

Completion Date:

Related Keywords:

  • Metastatic Renal Cell Carcinoma
  • Renal cell carcinoma
  • Sunitinib
  • phase II study
  • Randomized study
  • Carcinoma
  • Carcinoma, Renal Cell

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