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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01219751
Recruitment Status : Unknown
Verified September 2010 by Asan Medical Center.
Recruitment status was:  Active, not recruiting
First Posted : October 13, 2010
Last Update Posted : June 17, 2011
Sponsor:
Collaborators:
Samsung Medical Center
Seoul National University Hospital
Kyungpook National University Hospital
Information provided by:
Asan Medical Center

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

Condition or disease Intervention/treatment Phase
Metastatic Renal Cell Carcinoma Drug: Sunitinib Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial Of Sunitinib In Advanced Non-Clear Cell Type Renal Cell Carcinoma
Study Start Date : June 2008
Estimated Primary Completion Date : September 2011
Estimated Study Completion Date : September 2011


Arm Intervention/treatment
Experimental: Sunitinib
Sunitinib 50 mg D1-D28 every 6 weeks
Drug: Sunitinib
Sunitinib 50 mg D1-D28 every 6 weeks
Other Name: Sutene




Primary Outcome Measures :
  1. Response rate [ Time Frame: up to 12 months ]
    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 :
  1. Progression free survival [ Time Frame: up to 24 months ]
    Form the date of enrollment to the date of the first documented disease progression or death from any cause, which came first.

  2. overall survival [ Time Frame: up to 36 months ]
  3. Safety [ Time Frame: up to 24 months ]
    Safety will be assessed using CTCAE v.3.0



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01219751


Locations
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Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of, 138-736
Sponsors and Collaborators
Asan Medical Center
Samsung Medical Center
Seoul National University Hospital
Kyungpook National University Hospital
Investigators
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Study Chair: Jae-Lyun Lee, MD, PhD Asan Medical Center

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jae Lyun Lee/Professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT01219751    
Other Study ID Numbers: UOSG_AMC_0801
First Posted: October 13, 2010    Key Record Dates
Last Update Posted: June 17, 2011
Last Verified: September 2010
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Sunitinib
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action