Bevacizumab in Treating Patients With Unresectable or Metastatic Kidney Cancer
Stopped early · Phase 2
Conditions studied: Kidney Cancer
In brief
RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of kidney cancer by blocking blood flow to the tumor. PURPOSE: This phase II trial is studying the side effects and how well bevacizumab works in treating patients with unresectable or metastatic kidney cancer.
Key facts
- Study ID
- NCT00601926
- Run by
- Paul Monk
- People needed
- 5
- Starts
- 2008-02-01
- Expected to finish
- 2013-05-01
- Last updated by the study team
- 2015-06-15
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- ECOG (Eastern Cooperative Oncology Group) performance status 0-1
- Life expectancy > 6 months
- ANC (absolute neutrophil count) ≥ 1,000/mm\^3
- Platelet count ≥ 100,000/mm\^3
- Hemoglobin ≥ 10.0 g/dL
- Total bilirubin ≤ 2.0 mg/dL
- AST (aspartate aminotransferase) and ALT (Alanine transaminase) < 3 times normal
- Creatinine clearance > 50 mg/mL
- Calcium < 12 mg/dL (when corrected for level of serum albumin)
- No known HIV infection
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
You may not qualify if…
- Inadequately controlled hypertension (defined as systolic blood pressure [BP] > 150 mm Hg and/or diastolic BP > 100 mm Hg on antihypertensive medications)
- Prior history of hypertensive crisis or hypertensive encephalopathy
- New York Heart Association class II-IV congestive heart failure
- Myocardial infarction or unstable angina within the past 6 months
- Stroke or transient ischemic attack within the past 6 months
- Significant vascular disease (e.g., aortic aneurysm or aortic dissection)
- Symptomatic peripheral vascular disease
- Evidence of bleeding diathesis or coagulopathy
- Significant traumatic injury within the past 28 days
- Abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months
- Serious, non-healing wound, ulcer, or bone fracture
- Proteinuria at screening as demonstrated by either of the following:
- Urine protein:creatinine (UPC) ratio ≥ 1.0 at screening
- Urine dipstick for proteinuria ≥ 2+ OR 24-hour urine protein > 1g
- Known hypersensitivity to any component of bevacizumab
- PRIOR CONCURRENT THERAPY:
- No prior systemic treatment for metastatic papillary RCC
- At least 4 weeks since prior palliative radiotherapy of painful areas
- More than 28 days since prior major surgical procedure or open biopsy
- No concurrent major surgical procedure
- More than 7 days since prior core biopsy or other minor surgical procedure, excluding placement of a vascular access device
- Concurrent low-dose acetylsalicylic acid (≤ 325 mg/day) allowed in patients at high-risk for arterial thromboembolic disease
Where it is running
- Ohio State University Medical Center — Columbus, Ohio, United States
Full record on ClinicalTrials.gov
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