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

Metastatic Renal Cell Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01219751
• Other study ID #: UOSG_AMC_0801
• Status: Active, not recruiting
• Phase: Phase 2
• First received: October 12, 2010
• Last updated: June 16, 2011
• Start date: June 2008
• Est. completion date: September 2011

Study information

• Verified date: September 2010
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 35
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Metastatic Renal Cell Carcinoma

Intervention

Drug:
• Sunitinib
Sunitinib 50 mg D1-D28 every 6 weeks

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (4)

Lead Sponsor	Collaborator
Asan Medical Center	Kyungpook National University, Samsung Medical Center, Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate	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.	up to 12 months	No
Secondary	Progression free survival	Form the date of enrollment to the date of the first documented disease progression or death from any cause, which came first.	up to 24 months	No
Secondary	overall survival		up to 36 months	No
Secondary	Safety	Safety will be assessed using CTCAE v.3.0	up to 24 months	Yes