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Sponsors and Collaborators: |
Duke University National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00416637 |
RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some find tumor cells and kill them or carry tumor-killing substances to them. Others interfere with the ability of tumor cells to grow and spread. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor
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PURPOSE: This phase I trial is studying how well bevacizumab works in treating patients with advanced solid tumors.
Condition | Intervention | Phase |
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Unspecified Adult Solid Tumor, Protocol Specific |
Biological: bevacizumab |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Biomarker and Clinical Evaluation of Bevacizumab (Avastin) to Determine the Role of Nitric Oxide in Anti-VEGF Therapy |
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients receive bevacizumab IV over 30-90 minutes on days 1, 15, and 29. After the third dose of bevacizumab, patients may receive additional bevacizumab in combination with chemotherapy in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed solid tumor
PATIENT CHARACTERISTICS:
No proteinuria at baseline
Not pregnant or nursing
No arterial thromboembolic events within the past 6 months, including any of the following:
No serious cardiac arrhythmia requiring medication
PRIOR CONCURRENT THERAPY:
At least 2 weeks since prior and no concurrent antihypertensive agent(s)
No concurrent or recent (within past 10 days) use of full-dose oral or parenteral anticoagulants (heparin > 10,000/day or an INR > 1.5) or thrombolytic agents
Study ID Numbers: | CDR0000449969, DUMC-4907-05-6R2, GENENTECH-DUMC-4907-05-6R2 |
Study First Received: | December 27, 2006 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00416637 History of Changes |
Health Authority: | United States: Food and Drug Administration |
unspecified adult solid tumor, protocol specific |
Nitric Oxide Bevacizumab Angiogenesis Inhibitors |
Antineoplastic Agents Therapeutic Uses Growth Substances Physiological Effects of Drugs Growth Inhibitors |
Angiogenesis Modulating Agents Bevacizumab Angiogenesis Inhibitors Pharmacologic Actions |