Treatment Study Using Bevacizumab for Patients With Adrenocortical Carcinoma
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ClinicalTrials.gov Identifier: NCT00469469
Recruitment Status :
(unable to enroll subjects into the study)
This is a Phase II study of intravenous Bevacizumab in patients with pathologically confirmed nonresectable primary adrenocortical cancer (ACC). Patients must have received no prior therapy. They will receive Bevacizumab as a single agent every 2 weeks intravenously until disease progression. This study will be open at multiple sites.
Condition or disease
Adrenocortical carcinoma(ACC)is a rare malignancy with an incidence of 1.5 to 2 per million per year in the United states. Surgery is the only therapeutic option that can prolong survival. Currently there are no therapies that have been proven to prolong survival for patients with nonsurgically resectable disease. ACC has been shown to be highly resistant to standard chemotherapy, therefore, it is important that we test agents with mechanisms of action. This is a single arm phase II study of Bevacizumab, an angiogenesis inhibitor, given as a single agent at 10 mg/kg IV every 2 weeks in patients with unresectable ACC. Bevicizumab will be used as first line therapy. The study will test if Bevacizumab will be able to prolong the time to progression. If a delay in time to progression of 4 months or greater is seen, this will be considered clinically meaningful and further studies will be considered. This study will be conducted at multiple institutions (see below).
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Subjects must provide written informed consent
Subjects must be 18 years of age or older
Subjects must have histologically confirmed ACC by the Department of Pathology at Dartmouth-Hitchcock Medical Center
Subjects must have inoperable disease
This is a first and/or second line study. Patients must have completed only one or fewer regimes of systemic therapy. They may have received one prior systemic therapy either: a) mitotane, or b)chemotherapy, or c) experimental therapy, or d) concurrent chemotherapy and mitotane, or e) no prior systemic therapy
Subjects must have a life expectancy of three or more months
If subjects have received some form of systemic therapy (e.g. chemotherapy or mitotane), they should have completed that systemic therapy at least 28 days before beginning Bevacizumab
All subjects of child-bearing potential(men and women) must agree to the use of effective means of contraception
Other co-existing malignancies or malignancies diagnosed within the last 5 years wtih the exception of basal cell carcinoma or cervical cancer in situ
Any unresolved chronic toxicity greater than CTC grade 2 from previous anticancer therapy (except alopecia)
absolute neutrophil counts less than 1.5 x l,000,000,000/liter, or platelets less than 20.0 x 1,000,000,000/liter
As judged by the investigator, any evidence of severe or uncontrolled systemic disease (e.g., unstable or uncompensated respiratory,cardiac, hepatic, or renal disease)
Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the trial
Prior therapy with two or more systemic therapy regimes. In other words if a patient is seeking third line therapy or later than third line therapy he is ineligible for this study
Current, recent(within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study other than a Genentech- sponsored Bevacizumab cancer study
Prior use of Bevacizumab or any other anti-VEGF therapies
Known hypersensitivity to Bevacizumab
Inadequately controlled hypertension (defined as systolic blood pressure of >150 mm Hg and/or diastolic blood pressure >100 mm Hg on anti- hypertensive medications
Any prior history of hypertensive crisis or hypertensive encephalopathy
New York Heart Association (NYHA)Grade II or greater congestive heart failure
History of myocardial infarction within 6 months
History of stroke or transient ischemic attack at any time prior to study enrollment