Bevacizumab and Sunitinib in Treating Patients With Solid Tumors
A Phase I Study of Bevacizumab in Combination With SU11248
6 other identifiers
interventional
60
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2006
CompletedFirst Submitted
Initial submission to the registry
July 26, 2006
CompletedFirst Posted
Study publicly available on registry
July 27, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2012
CompletedFebruary 24, 2014
June 1, 2013
6.1 years
July 26, 2006
February 21, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Maximum tolerated dose (MTD) of bevacizumab in combination with sunitinib malate determined according to dose-limiting toxicities (DLTs) graded using Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0)
42 days
Secondary Outcomes (3)
Objective response rate assessed by RECIST
Up to 5 years
Overall survival
Up to 5 years
Progression-free survival
Up to 5 years
Study Arms (1)
Treatment (sunitinib malate, bevacizumab)
EXPERIMENTALPatients receive bevacizumab IV over 30-90 minutes on days 1, 15, and 29 and oral sunitinib malate (SU11248) once daily on days 1-28. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
Interventions
Given PO
Given IV
Correlative studies
Eligibility Criteria
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
- +40 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Case Western Reserve University
Cleveland, Ohio, 44106, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Brian Rini
Case Comprehensive Cancer Center
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 26, 2006
First Posted
July 27, 2006
Study Start
June 1, 2006
Primary Completion
July 1, 2012
Last Updated
February 24, 2014
Record last verified: 2013-06