A Phase II Study of Bevacizumab in Patients With Nonresectable Cancer of the Adrenal Cortex.
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