Clinical trial · Interventional
Treatment Study Using Bevacizumab for Patients With Adrenocortical Carcinoma
A Phase II Study of Bevacizumab in Patients With Nonresectable Cancer of the Adrenal Cortex.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): unable to enroll subjects into the study
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adrenocortical Carcinoma | Adrenal Cortical Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bevacizumab | Drug | Bevacizumab | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- To measure time to progression
- timeFrame
- From date of first dose of Bevacizumab until progression.
Secondary outcomes (3)
- measure
- To Measure objective response rate by RECIST
- timeFrame
- At the end of treatment, RECIST criteria will be used to determine the patient's best overall response.
- measure
- To determine an adverse event profile
- timeFrame
- Measured from date of first treatment until 30 days post treatment.
- measure
- To measure survival in all treated patients.
- timeFrame
- Survival is measured from the date of first treatment to date of death form any cause.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available