RAD001 Plus Bevacizumab in Metastatic Melanoma
A Phase II Trial of RAD001 Plus Bevacizumab in the Treatment of Patients With Metastatic Melanoma
1 other identifier
interventional
57
1 country
15
Brief Summary
This is a non-randomized, open label Phase II study comparing bevacizumab and everolimus in the treatment of metastatic melanoma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jan 2008
Typical duration for phase_2
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 26, 2007
CompletedStudy Start
First participant enrolled
January 1, 2008
CompletedFirst Posted
Study publicly available on registry
January 11, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2011
CompletedResults Posted
Study results publicly available
February 26, 2013
CompletedNovember 24, 2021
November 1, 2021
2.8 years
December 26, 2007
January 22, 2013
November 22, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression-free Survival
Length of time, in months, that patients were alive from their first date of protocol treatment until worsening of their disease
13 months
Secondary Outcomes (2)
Overall Survival Rate
1 year
Objective Response Rate (ORR)
13 months
Study Arms (1)
Intervention
EXPERIMENTALAll patients received bevacizumab 15 mg/kg, administered by intravenous (IV) infusion on day 1 of each 21 day course. In addition, patients received everolimus 10 mg orally on a daily basis.
Interventions
15 mg/kg of bevacizumab intravenously (IV) once every 3 weeks.
Eligibility Criteria
You may qualify if:
- Histologically confirmed melanoma.
- Unresectable stage IV disease, or recurrent disease with metastases.
- Measurable disease (by Response Evaluation Criteria in Solid Tumors \[RECIST\]) or measurable skin lesions.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2.
- Life expectancy \>=12 weeks.
- Patients are allowed 0-2 prior treatment regimens containing chemotherapy and/or immunotherapy (interferon, interleukin 2).
- Women of childbearing potential must have a negative serum pregnancy test with 7 days before beginning treatment.
- Absolute neutrophil count (ANC) \>=1500/µL, and platelets \>=100,000/µL.
- Serum creatinine \<=2.0 mg/dL.
- Serum bilirubin \<=1.5 mg/dL institutional upper limit of normal (ULN); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \<2.5 × ULN or \<5 × ULN in patients with documented liver metastases.
You may not qualify if:
- Previous treatment with bevacizumab or other anti-angiogenesis agents.
- Previous treatment with mTOR inhibitors.
- Drugs or substances known to be inhibitors or inducers of the isoenzyme CYP3A are not allowed.
- Treatment with investigational agents within 4 weeks of study entry.
- Treatment with more than two previous chemotherapy regimens.
- Immunization with attenuated live vaccines within one week of study or anytime during study treatment period.
- Female patients who are pregnant or breastfeeding.
- Central nervous system (CNS) involvement by metastatic melanoma.
- CNS disease (e.g., seizures not controlled with standard medical therapy, history of stroke).
- Any severe and/or uncontrolled medical conditions or other conditions that could affect participation in the study such as:
- Severely impaired lung function.
- Uncontrolled diabetes as defined by fasting serum glucose \>1.5 ULN,
- Any acute or chronic uncontrolled infection/disorder.
- Non-malignant medical illnesses that are uncontrolled or whose control may be jeopardize by the treatment with the study therapy.
- Any acute or chronic uncontrolled infection/disorder.
- +12 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- SCRI Development Innovations, LLClead
- Genentech, Inc.collaborator
- Novartiscollaborator
Study Sites (15)
Florida Cancer Specialists
Fort Myers, Florida, 33901, United States
Watson Clinic Center for Cancer Care and Research
Lakeland, Florida, 33805, United States
Florida Hospital Cancer Institute
Orlando, Florida, 32804, United States
Gulfcoast Oncology Associates
St. Petersburg, Florida, 33705, United States
Northeast Georgia Medical Center
Gainesville, Georgia, 30501, United States
Oncology Hematology Associates of SW Indiana
Evansville, Indiana, 47714, United States
Center for Cancer and Blood Disorders
Bethesda, Maryland, 20817, United States
Grand Rapids Clinical Oncology Program
Grand Rapids, Michigan, 49503, United States
St. Louis Cancer Care
Chesterfield, Missouri, 63017, United States
Methodist Cancer Center
Omaha, Nebraska, 68114, United States
Consultants in Medical Oncology and Hematology
Drexel Hill, Pennsylvania, 19026, United States
Chattanooga Oncology & Hematology Associates
Chattanooga, Tennessee, 37404, United States
Tennessee Oncology, PLLC
Nashville, Tennessee, 37023, United States
South Texas Oncology and Hematology
San Antonio, Texas, 78258, United States
Virginia Cancer Institute
Richmond, Virginia, 23235, United States
Related Publications (1)
Hainsworth JD, Infante JR, Spigel DR, Peyton JD, Thompson DS, Lane CM, Clark BL, Rubin MS, Trent DF, Burris HA 3rd. Bevacizumab and everolimus in the treatment of patients with metastatic melanoma: a phase 2 trial of the Sarah Cannon Oncology Research Consortium. Cancer. 2010 Sep 1;116(17):4122-9. doi: 10.1002/cncr.25320.
PMID: 20564157RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- John Hainsworth, MD
- Organization
- Sarah Cannon Research Institute
Study Officials
- STUDY CHAIR
John D. Hainsworth, M.D.
SCRI Development Innovations, LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 26, 2007
First Posted
January 11, 2008
Study Start
January 1, 2008
Primary Completion
October 1, 2010
Study Completion
October 1, 2011
Last Updated
November 24, 2021
Results First Posted
February 26, 2013
Record last verified: 2021-11