Treatment Study Using Bevacizumab for Patients With Adrenocortical Carcinoma

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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