Status:
UNKNOWN
Trial Of Sunitinib In Advanced Non-Clear Cell Type Renal Cell Carcinoma
Lead Sponsor:
Asan Medical Center
Collaborating Sponsors:
Samsung Medical Center
Seoul National University Hospital
Conditions:
Metastatic Renal Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
To evaluate the efficacy and safety of sunitinib in non-clear cell type renal cell carcinoma with the exception of pure sarcomatoid carcinoma and collecting duct carcinoma
Detailed Description
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 pap...
Eligibility Criteria
Inclusion
- Histologically or cytologically confirmation of renal cell carcinoma without a clear cell histologic component, e.g., papillary type, chromophobe type, or collecting duct type
- Patients with stage IV or recurrent disease not amenable to surgery, radiotherapy, or combined modality therapy with curative intent.
- Measurable disease according to RECIST criteria
- ECOG performance status 1 or better
- Age 18 years or older
- Adequate cardiac function
- 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
- Clear cell type renal cell carcinoma or sarcomatoid carcinoma without any clue to the primary type
- 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.
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2011
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT01219751
Start Date
June 1 2008
End Date
September 1 2011
Last Update
June 17 2011
Active Locations (1)
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1
Asan Medical Center
Seoul, Seoul, South Korea, 138-736