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Phase II Trial Of Sunitinib In Advanced Non-Clear Cell Type Renal Cell Carcinoma

Phase 2
18 Years
Open (Enrolling)
Metastatic Renal Cell Carcinoma

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Trial Information

Phase II Trial Of Sunitinib In Advanced Non-Clear Cell Type Renal Cell Carcinoma

There have been no standard treatment in non-clear cell renal cell carcinoma. Retrospective
studies showed sunitinib or sorafenib might be active in non-clear cell renal cell
carcinoma, especially papillary type and chromophobe type.

This study is to evaluate efficacy and safety of sunitinib in this group of patients.

Inclusion Criteria:

1. Histologically or cytologically confirmation of renal cell carcinoma without a clear
cell histologic component, e.g., papillary type, chromophobe type, or collecting duct

2. Patients with stage IV or recurrent disease not amenable to surgery, radiotherapy, or
combined modality therapy with curative intent.

3. Measurable disease according to RECIST criteria

4. ECOG performance status 1 or better

5. Age 18 years or older

6. Adequate cardiac function

7. Adequate bone marrow, hepatic, and renal function

8. Life expectancy of ≥ 3 months

9. 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. Clear cell type renal cell carcinoma or sarcomatoid carcinoma without any clue to the
primary type

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:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate

Outcome Description:

Tumor response is to be measured every 6 weeks. RECIST v.1.1 will be used to definte target lesion and non-target lesion and classify the response category.

Outcome Time Frame:

up to 12 months

Safety Issue:


Principal Investigator

Jae-Lyun Lee, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Asan Medical Center


Korea: Food and Drug Administration

Study ID:




Start Date:

June 2008

Completion Date:

September 2011

Related Keywords:

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