Treatment Study Using Bevacizumab for Patients With Adrenocortical Carcinoma

NCT00469469 | Withdrawn Phase 2 DMC

• 1 other identifier: DMS 0510
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Adrenocortical Carcinoma

Keywords

Adrenal Cortex; ACC

Outcome Measures

Primary Outcomes (1)

• To measure time to progression

  From date of first dose of Bevacizumab until progression.

Secondary Outcomes (3)

• To Measure objective response rate by RECIST

  At the end of treatment, RECIST criteria will be used to determine the patient's best overall response.

• To determine an adverse event profile

  Measured from date of first treatment until 30 days post treatment.

• To measure survival in all treated patients.

  Survival is measured from the date of first treatment to date of death form any cause.

Interventions

Bevacizumab DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead
• Genentech, Inc.: collaborator

Study Sites (1)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

MeSH Terms

Conditions

Adrenocortical Carcinoma

Interventions

Bevacizumab

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Adrenal Cortex Neoplasms; Adrenal Gland Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Adrenal Cortex Diseases; Adrenal Gland Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Vivek Samnotra, MD

  Dartmouth-Hitchcock Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 2, 2007
• First Posted: May 4, 2007
• Study Start: May 1, 2007
• Study Completion: September 1, 2009
• Last Updated: April 22, 2015

Record last verified: 2008-05

Locations

US (1)