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

Phase 2
18 Years
Not Enrolling
Adrenocortical Carcinoma

Thank you

Trial Information

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

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).

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

- 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

- Urine protein: creatinine ratio > 1.0 at screening -History of abdominal fistula,
gastrointestinal perforation, or intr- abdominal abcess within 6 months prior to Day

- Serious, non-healing wound, ulcer, or bone fracture

- Lung lesions of any etiology(malignant or nonmalignant) in close proximity to a major

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

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

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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To measure time to progression

Outcome Time Frame:

From date of first dose of Bevacizumab until progression.

Principal Investigator

Vivek Samnotra, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dartmouth-Hitchcock Medical Center


United States: Food and Drug Administration

Study ID:

DMS 0510



Start Date:

May 2007

Completion Date:

September 2009

Related Keywords:

  • Adrenocortical Carcinoma
  • Adrenal Cortex
  • ACC
  • Carcinoma
  • Adrenocortical Carcinoma
  • Adrenal Cortex Neoplasms



Dartmouth-Hitchcock Medical CenterLebanon, New Hampshire  03756