Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE2
57 participants
INTERVENTIONAL
2008-01-31
2011-10-31
Brief Summary
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Detailed Description
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During the study, all patients will receive 10 mg of RAD001 orally daily and 15 mg/kg of bevacizumab intravenously (IV) once every 3 weeks.
Fifty-five patients will be enrolled in this multi-centered study
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Intervention
All 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.
Bevacizumab
15 mg/kg of bevacizumab intravenously (IV) once every 3 weeks.
Everolimus
10 mg by mouth daily
Interventions
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Bevacizumab
15 mg/kg of bevacizumab intravenously (IV) once every 3 weeks.
Everolimus
10 mg by mouth daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Unresectable stage IV disease, or recurrent disease with metastases.
3. Measurable disease (by Response Evaluation Criteria in Solid Tumors \[RECIST\]) or measurable skin lesions.
4. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2.
5. Life expectancy \>=12 weeks.
6. Patients are allowed 0-2 prior treatment regimens containing chemotherapy and/or immunotherapy (interferon, interleukin 2).
7. Women of childbearing potential must have a negative serum pregnancy test with 7 days before beginning treatment.
8. Absolute neutrophil count (ANC) \>=1500/µL, and platelets \>=100,000/µL.
9. Serum creatinine \<=2.0 mg/dL.
10. 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.
Exclusion Criteria
2. Previous treatment with mTOR inhibitors.
3. Drugs or substances known to be inhibitors or inducers of the isoenzyme CYP3A are not allowed.
4. Treatment with investigational agents within 4 weeks of study entry.
5. Treatment with more than two previous chemotherapy regimens.
6. Immunization with attenuated live vaccines within one week of study or anytime during study treatment period.
7. Female patients who are pregnant or breastfeeding.
8. Central nervous system (CNS) involvement by metastatic melanoma.
9. CNS disease (e.g., seizures not controlled with standard medical therapy, history of stroke).
10. 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.
* Non-malignant medical illnesses that are uncontrolled or whose control may be jeopardize by the treatment with the study therapy.
* Liver disease such as cirrhosis, chronic active hepatitis or chronic persistent hepatitis.
11. Acute myocardial infarction (MI) with the previous 6 months.
12. Clinically significant cardiovascular disease (e.g., uncontrolled hypertension, unstable angina, New York Heart Association \[NYHA\] Class II or greater congestive heart failure \[CHF\], serious cardiac arrhythmia requiring medication), or \>= grade 2 vascular disease.
13. Clinical history of hemoptysis or hematemesis.
14. Clinical evidence or history of a bleeding diathesis or coagulopathy.
15. Major surgical procedures, fine-needle aspirations, or core biopsies with 7 days of starting treatment.
16. Patients with PEG tubes or G-tubes.
17. Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of RAD001 (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection).
18. Proteinuria at screening as demonstrated by either
1. Urine protein:creatinine (UPC) ratio \>= 1.0 at screening OR
2. Urine dipstick for proteinuria \>= 2+ (patients discovered to have \>=2+ proteinuria on dipstick urinalysis at baseline should undergo a 24 hour urine collection and must demonstrate \<= 1g of protein in 24 hours to be eligible).
18 Years
ALL
No
Sponsors
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Genentech, Inc.
INDUSTRY
Novartis
INDUSTRY
SCRI Development Innovations, LLC
OTHER
Responsible Party
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Principal Investigators
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John D. Hainsworth, M.D.
Role: STUDY_CHAIR
SCRI Development Innovations, LLC
Locations
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Florida Cancer Specialists
Fort Myers, Florida, United States
Watson Clinic Center for Cancer Care and Research
Lakeland, Florida, United States
Florida Hospital Cancer Institute
Orlando, Florida, United States
Gulfcoast Oncology Associates
St. Petersburg, Florida, United States
Northeast Georgia Medical Center
Gainesville, Georgia, United States
Oncology Hematology Associates of SW Indiana
Evansville, Indiana, United States
Center for Cancer and Blood Disorders
Bethesda, Maryland, United States
Grand Rapids Clinical Oncology Program
Grand Rapids, Michigan, United States
St. Louis Cancer Care
Chesterfield, Missouri, United States
Methodist Cancer Center
Omaha, Nebraska, United States
Consultants in Medical Oncology and Hematology
Drexel Hill, Pennsylvania, United States
Chattanooga Oncology & Hematology Associates
Chattanooga, Tennessee, United States
Tennessee Oncology, PLLC
Nashville, Tennessee, United States
South Texas Oncology and Hematology
San Antonio, Texas, United States
Virginia Cancer Institute
Richmond, Virginia, United States
Countries
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References
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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.
Other Identifiers
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SCRI MEL 16
Identifier Type: -
Identifier Source: org_study_id