Status:
WITHDRAWN
Treatment Study Using Bevacizumab for Patients With Adrenocortical Carcinoma
Lead Sponsor:
Dartmouth-Hitchcock Medical Center
Collaborating Sponsors:
Genentech, Inc.
Conditions:
Adrenocortical Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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...
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 t...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00469469
Start Date
May 1 2007
End Date
September 1 2009
Last Update
April 22 2015
Active Locations (1)
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1
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756