Bevacizumab and Sunitinib in Treating Patients With Solid Tumors

Completed · Phase 1

Conditions studied: Unspecified Adult Solid Tumor, Protocol Specific

In brief

This phase I trial is studying the side effects and best dose of bevacizumab and sunitinib in treating patients with solid tumors. 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. Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Bevacizumab and sunitinib may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving bevacizumab together with sunitinib may kill more tumor cells.

Key facts

Study ID

NCT00357318

Run by

National Cancer Institute (NCI)

People needed

60

Starts

2006-06-01

Last updated by the study team

2014-02-24

Who can join

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

You may qualify if…

• Histologically proven metastatic/unresectable adrenocortical carcinoma or melanoma not amenable to curative surgical or radiation therapy.
• Accrual closed as of 5/27/2009 to patients with renal cell carcinoma
• No squamous cell histology
• No histology in close proximity to a major blood vessel
• No history of or known brain metastases, spinal cord compression, or carcinomatous meningitis
• No new evidence of brain or leptomeningeal disease on screening CT scan or MRI
• ECOG performance status (PS) 0-1 OR Karnofsky PS 60-100%
• AST and ALT ≤ 2.5 times upper limit of normal (ULN)
• Bilirubin ≤ 1.5 times ULN
• Creatinine ≤ 1.5 times ULN
• Absolute neutrophil count ≥ 1,500/mm³
• Platelet count ≥100,000/mm³
• Hemoglobin ≥ 10.0 g/dL
• Calcium ≤ 12.0 mg/dL
• Urine protein:creatinine ratio ≤ 0.5 by urinalysis
• Patients with urine protein:creatinine ratio > 0.5 must have proteinuria < 1,000 mg by 24-hour urine collection
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for ≥ 6 months after completion of study therapy
• None of the following within the past 12 months:
• Myocardial infarction
• Severe/unstable angina
• Severe peripheral vascular disease (claudication) or procedure on peripheral vasculature
• Coronary/peripheral artery bypass graft
• New York Heart Association (NYHA) grade III-IV congestive heart failure

Where it is running

• Case Western Reserve University — Cleveland, Ohio, United States
• Cleveland Clinic Foundation — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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