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

NCT ID: NCT01219751

Last Updated: 2011-06-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-06-30
• Study Completion Date: 2011-09-30

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.

Conditions

Metastatic Renal Cell Carcinoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Sunitinib

Sunitinib 50 mg D1-D28 every 6 weeks

Group Type: EXPERIMENTAL

Sunitinib

Intervention Type: DRUG

Sunitinib 50 mg D1-D28 every 6 weeks

Interventions

Sunitinib

Sunitinib 50 mg D1-D28 every 6 weeks

Intervention Type: DRUG

Other Intervention Names

Sutene

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Samsung Medical Center

OTHER

Sponsor Role: collaborator

Seoul National University Hospital

OTHER

Sponsor Role: collaborator

Kyungpook National University Hospital

OTHER

Sponsor Role: collaborator

Asan Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Asan Medical Center

Principal Investigators

Jae-Lyun Lee, MD, PhD

Role: STUDY_CHAIR

Asan Medical Center

Locations

Asan Medical Center

Seoul, Seoul, South Korea

Countries

South Korea

References

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.

Reference Type: DERIVED

PMID: 22228449 (View on PubMed)

Other Identifiers

UOSG_AMC_0801

Identifier Type: -

Identifier Source: org_study_id