Clinical trial NCT01219751: Trial Of Sunitinib In Advanced Non-Clear Cell Type Renal Cell Carcinoma
Official title: Phase II Trial Of Sunitinib In Advanced Non-Clear Cell Type Renal Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Metastatic Renal Cell Carcinoma
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
Collaborators: name: Samsung Medical Center
name: Seoul National University Hospital
name: Kyungpook National University Hospital
First posted: 2010-10-13
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Response rate
timeFrame: up to 12 months
Secondary outcomes:
measure: Progression free survival
timeFrame: up to 24 months
measure: overall survival
timeFrame: up to 36 months
measure: Safety
timeFrame: up to 24 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Asan Medical Center
name: Jae-Lyun Lee, MD, PhD
role: STUDY_CHAIR
References:
citation: Lee JL, Ahn JH, Lim HY, Park SH, Lee SH, Kim TM, Lee DH, Cho YM, Song C, Hong JH, Kim CS, Ahn H. Multicenter phase II study of sunitinib in patients with non-clear cell renal cell carcinoma. Ann Oncol. 2012 Aug;23(8):2108-2114. doi: 10.1093/annonc/mdr586. Epub 2012 Jan 6.