Status:
COMPLETED
Sunitinib Malate in Treating Patients With Previously Untreated Metastatic Kidney Cancer
Lead Sponsor:
Case Comprehensive Cancer Center
Conditions:
Clear Cell Renal Cell Carcinoma
Stage IV Renal Cell Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 ...
Detailed Description
PRIMARY OBJECTIVES: I. To determine the feasibility of intermittent sunitinib therapy in patients with metastatic renal cell carcinoma (RCC). SECONDARY OBJECTIVES: I. To determine the clinical outc...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 18 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2017
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT01158222
Start Date
August 18 2010
End Date
February 1 2017
Last Update
September 14 2018
Active Locations (1)
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1
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44195