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

Phase 2

• Conditions: Metastatic Renal Cell Carcinoma
• Interventions: Drug: Sunitinib

• Registration Number: NCT01219751
• Lead Sponsor: Asan Medical Center

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 papillary type and chromophobe type.

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

Study Timeline

• Study Start: 2008-06
• Status Verified: 2010-09
• Study First Submitted: 2010-10-12
• Study First Submitted QC: 2010-10-12
• Study First Posted: 2010-10-13
• Last Update Submitted: 2011-06-16
• Last Update Posted: 2011-06-17
• Primary Completion: 2011-09
• Study Completion: 2011-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 35

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 type
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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sunitinib	Sunitinib	Sunitinib 50 mg D1-D28 every 6 weeks

Primary Outcome Measures

Name	Time	Method
Response rate	up to 12 months	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.

Secondary Outcome Measures

Name	Time	Method
Progression free survival	up to 24 months	Form the date of enrollment to the date of the first documented disease progression or death from any cause, which came first.
overall survival	up to 36 months
Safety	up to 24 months	Safety will be assessed using CTCAE v.3.0

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of