Brief Title
Treatment Study Using Bevacizumab for Patients With Adrenocortical Carcinoma
Official Title
A Phase II Study of Bevacizumab in Patients With Nonresectable Cancer of the Adrenal Cortex.
Brief 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.
Detailed Description
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).
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
To measure time to progression
Secondary Outcome
To Measure objective response rate by RECIST
Condition
Adrenocortical Carcinoma
Intervention
Bevacizumab
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
0
Start Date
May 2007
Completion Date
September 2009
Eligibility 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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Vivek Samnotra, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00469469
Organization ID
DMS 0510
Study Sponsor
Dartmouth-Hitchcock Medical Center
Collaborators
Genentech, Inc.
Study Sponsor
Vivek Samnotra, MD, Principal Investigator, Dartmouth-Hitchcock Medical Center
Verification Date
May 2008