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

Primary Purpose

Metastatic Renal Cell Carcinoma

Status
Unknown status
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Sunitinib
Sponsored by
Asan Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Renal Cell Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Asan Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Sunitinib

Arm Description

Sunitinib 50 mg D1-D28 every 6 weeks

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
overall survival
Safety
Safety will be assessed using CTCAE v.3.0

Full Information

First Posted
October 12, 2010
Last Updated
June 16, 2011
Sponsor
Asan Medical Center
Collaborators
Samsung Medical Center, Seoul National University Hospital, Kyungpook National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01219751
Brief Title
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

2. Study Status

Record Verification Date
September 2010
Overall Recruitment Status
Unknown status
Study Start Date
June 2008 (undefined)
Primary Completion Date
September 2011 (Anticipated)
Study Completion Date
September 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Asan Medical Center
Collaborators
Samsung Medical Center, Seoul National University Hospital, Kyungpook National University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Renal Cell Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
35 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sunitinib
Arm Type
Experimental
Arm Description
Sunitinib 50 mg D1-D28 every 6 weeks
Intervention Type
Drug
Intervention Name(s)
Sunitinib
Other Intervention Name(s)
Sutene
Intervention Description
Sunitinib 50 mg D1-D28 every 6 weeks
Primary Outcome Measure Information:
Title
Response rate
Description
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.
Time Frame
up to 12 months
Secondary Outcome Measure Information:
Title
Progression free survival
Description
Form the date of enrollment to the date of the first documented disease progression or death from any cause, which came first.
Time Frame
up to 24 months
Title
overall survival
Time Frame
up to 36 months
Title
Safety
Description
Safety will be assessed using CTCAE v.3.0
Time Frame
up to 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically or cytologically confirmation of renal cell carcinoma without a clear cell histologic component, e.g., papillary type, chromophobe type, or collecting duct type Patients with stage IV or recurrent disease not amenable to surgery, radiotherapy, or combined modality therapy with curative intent. Measurable disease according to RECIST criteria ECOG performance status 1 or better Age 18 years or older Adequate cardiac function Adequate bone marrow, hepatic, and renal function Life expectancy of ≥ 3 months 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: Clear cell type renal cell carcinoma or sarcomatoid carcinoma without any clue to the primary type 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 Hypertension that cannot be controlled by medications (blood pressure > 150/90 mmHg despite optimal medical therapy) 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). Pregnancy or breast feeding. Other severe acute or chronic medical or psychiatric condition Prior treatment on sunitinib, sorafenib, or bevacizumab.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jae-Lyun Lee, MD, PhD
Organizational Affiliation
Asan Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
22228449
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.
Results Reference
derived

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

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