Treatment Study Using Bevacizumab for Patients With Adrenocortical Carcinoma

• Status: Withdrawn
• Trial end date: 2009-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dartmouth-Hitchcock Medical Center
• Collaborator: Genentech, Inc.
• Treatments: Bevacizumab

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

• Cavitary lung lesions (to prevent episodes of potentially life-threatening hemoptysis)

• History of hemoptysis (defined as bright red blood of 1/2 teaspoon or more)

• Inability to comply with study and/or follow-up procedures