Treatment Study Using Bevacizumab for Patients With Adrenocortical Carcinoma (NCT00469469) | Clinical Trial Compass
WithdrawnPhase 2
Treatment Study Using Bevacizumab for Patients With Adrenocortical Carcinoma
Stopped: unable to enroll subjects into the study
United States0Started 2007-05
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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, hepat…
What they're measuring
1
To measure time to progression
Timeframe: From date of first dose of Bevacizumab until progression.