Treatment Study Using Bevacizumab for Patients With Adrenocortical Carcinoma

Withdrawn before enrolling · Phase 2

Conditions studied: Adrenocortical Carcinoma

In brief

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.

Key facts

Study ID

NCT00469469

Run by

Dartmouth-Hitchcock Medical Center

People needed

0

Starts

2007-05-01

Expected to finish

2009-09-01

Last updated by the study team

2015-04-22

Who can join

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

You may qualify if…

• 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

You may not qualify if…

• 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
• Unstable angina
• 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
• Clinically significant peripheral vascular disease
• Evidence of bleeding diathesis or coagulopathy
• Presence of central nervous system or brain metastases
• Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 0, anticipation of need for major surgical procedure during the course of the study
• Core biopsies or other minor surgical procedures, excluding placement of a vascular access device, within 7 days prior to Day 0
• Pregnant (positive pregnancy test) or lactating
• Women who are fertile and not willing to practice abstinence or an adequate form of contraception (i.e. use or oral contraceptives, intrauterine devices or barrier protection)
• Urine protein: creatinine ratio > 1.0 at screening -History of abdominal fistula, gastrointestinal perforation, or intr- abdominal abcess within 6 months prior to Day 0
• Serious, non-healing wound, ulcer, or bone fracture
• Lung lesions of any etiology(malignant or nonmalignant) in close proximity to a major vessel

Where it is running

• Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States

Full record on ClinicalTrials.gov

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