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

Asan Medical Center

Status and phase: Unknown; Phase 2

Conditions: Metastatic Renal Cell Carcinoma

Treatments: Drug: Sunitinib

Study type: Interventional

Funder types: Other

Identifiers

NCT01219751

UOSG_AMC_0801

Details and patient eligibility

About

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

Full 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.

Enrollment: 35 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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35 participants in 1 patient group

Sunitinib

Experimental group

Description:

Sunitinib 50 mg D1-D28 every 6 weeks

Treatment:

Drug: Sunitinib