Sunitinib Malate in Treating Patients With Previously Untreated Metastatic Kidney Cancer

Completed · Phase 2

Conditions studied: Clear Cell Renal Cell Carcinoma, Stage IV Renal Cell Cancer

In brief

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.

Key facts

Study ID

NCT01158222

Run by

Case Comprehensive Cancer Center

People needed

37

Starts

2010-08-18

Expected to finish

2017-02-01

Last updated by the study team

2018-09-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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