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Sunitinib Malate in Treating Patients With Previously Untreated Metastatic Kidney Cancer

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. Identifier: NCT01158222
Recruitment Status : Completed
First Posted : July 8, 2010
Results First Posted : August 16, 2018
Last Update Posted : September 14, 2018
Information provided by (Responsible Party):
Case Comprehensive Cancer Center

Brief Summary:

RATIONALE: Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth or by blocking blood flow to the tumor.

PURPOSE: This phase II trial is studying how well sunitinib malate it works in treating patients with previously untreated metastatic kidney cancer.

Condition or disease Intervention/treatment Phase
Clear Cell Renal Cell Carcinoma Stage IV Renal Cell Cancer Drug: sunitinib malate Phase 2

Detailed Description:


I. To determine the feasibility of intermittent sunitinib therapy in patients with metastatic renal cell carcinoma (RCC).


I. To determine the clinical outcome (response rate and overall progression-free survival) in metastatic renal cell carcinoma patients treated with intermittent sunitinib therapy.

II. To evaluate the toxicity of intermittent sunitinib therapy in patients with metastatic renal cell carcinoma.

III. To assess the feasibility of detecting circulating tumor cells (CTCs) in RCC patients and investigate the association between the VEGF -634 genotype and the occurrence of hypertension in sunitinib-treated RCC patients.


Patients receive oral sunitinib malate once daily on days 1-28. Sunitinib dosing schedule may be changed to 14 days on followed by 7 days off, and repeated for a 6-week cycle, at the discretion of the treating physician for toxicity purposes. Cycles will be defined as 6 week intervals regardless of dosing interruptions. All patients will be treated for 4 cycles in the absence of unacceptable toxicity or RECIST-defined progressive disease.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Intermittent Sunitinib in Previously Untreated Patients With Metastatic Renal Cell Carcinoma
Actual Study Start Date : August 18, 2010
Actual Primary Completion Date : June 20, 2013
Actual Study Completion Date : February 1, 2017

Arm Intervention/treatment
Experimental: Arm I
Patients receive oral sunitinib malate once daily on days 1-28. Treatment repeats every 42 days for at least 4 courses in the absence of disease progression or unacceptable toxicity.
Drug: sunitinib malate
Given orally
Other Names:
  • SU011248
  • SU11248
  • sunitinib
  • Sutent

Primary Outcome Measures :
  1. Feasibility as Assessed by Proportion of Patients Eligible for Intermittent Therapy Who Actually Receive it [ Time Frame: after 6 months of treatment (4 cycles) ]
    Treatment repeats every 42 days for at least 4 courses in the absence of disease progression or unacceptable toxicity.

Secondary Outcome Measures :
  1. Change in Circulating Tumor Cells [ Time Frame: Pre-treatment, day 1, and day 28 of every cycle ]
  2. Relationship Between Hypertension and Germline VEGF Single Nucleotide Polymorphism (SNP) -634 Genotype [ Time Frame: Day 28 of each cycle ]

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Histologically or cytologically-proven advanced RCC with a component of clear cell histology
  • Measurable disease per RECIST criteria
  • ECOG performance status 0-1
  • Prior nephrectomy is NOT required
  • Serum aspartate transaminase (AST; serum glutamic oxaloacetic transaminase [SGOT]) and serum alanine transaminase (ALT; serum glutamic pyruvic transaminase [SGPT]) ≤ 2.5 x laboratory upper limit of normal (ULN)
  • Total serum bilirubin ≤ 2.0 x ULN
  • Absolute neutrophil count (ANC) ≥ 1500/uL
  • Platelets ≥ 100,000/uL
  • Hemoglobin ≥ 8.0 g/dL (transfusion permitted)
  • Serum calcium ≤ 12.0 mg/dL
  • Serum creatinine ≤ 2.5 mg/dL
  • Patients with history of brain metastases can be enrolled at a minimum of 2 weeks following the completion of surgery, gamma knife or whole brain radiotherapy; repeat brain MRI not required for eligibility
  • Signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all pertinent aspects of the trial prior to enrollment

Exclusion Criteria:

  • Prior systemic treatment for advanced RCC. Prior adjuvant therapy (any drug) is allowed if end of adjuvant therapy was more than 1 year prior to start of sunitinib on this protocol.
  • Any of the following within the 6 months prior to study drug administration: myocardial infarction, severe/unstable angina, severe peripheral vascular disease (claudication) or procedure on peripheral vasculature, coronary/peripheral artery bypass graft, New York Heart Association grade II or greater congestive heart failure, cerebrovascular accident or transient ischemic attack, clinically significant bleeding or pulmonary embolism
  • Hypertension that cannot be controlled by medications to < 160/90 mmHg
  • Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness
  • Pregnancy or breastfeeding
  • Other severe acute or chronic medical or psychiatric conditions or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the patient inappropriate for entry into this study

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 identifier (NCT number): NCT01158222

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United States, Ohio
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
Case Comprehensive Cancer Center
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Principal Investigator: Brian Rini Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

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Responsible Party: Case Comprehensive Cancer Center Identifier: NCT01158222     History of Changes
Other Study ID Numbers: CASE8809
NCI-2010-01391 ( Other Identifier: NCI/CTRP )
First Posted: July 8, 2010    Key Record Dates
Results First Posted: August 16, 2018
Last Update Posted: September 14, 2018
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Protein Kinase Inhibitors
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action