Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:47 PM
Ignite Modification Date:
2025-12-24 @ 10:47 PM
NCT ID:
NCT00469469
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00469469
Study Brief:
Protocol Section:
NCT00469469