Study of Everolimus With Paclitaxel and Carboplatin in Patients With Metastatic Melanoma
A Phase II Study of Everolimus in Combination With Paclitaxel and Carboplatin in Patients With Metastatic Melanoma
1 other identifier
interventional
70
1 country
12
Brief Summary
Based on data demonstrating synergy between paclitaxel and mammalian target of rapamycin (mTOR) inhibition, the investigators propose that the addition of everolimus to paclitaxel with carboplatin should lead to improvements in efficacy as measured by progression-free survival and response rate.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Feb 2010
Typical duration for phase_2
12 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
November 16, 2009
CompletedFirst Posted
Study publicly available on registry
November 17, 2009
CompletedStudy Start
First participant enrolled
February 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2013
CompletedResults Posted
Study results publicly available
March 26, 2014
CompletedMarch 26, 2014
January 1, 2014
2 years
November 16, 2009
February 10, 2014
February 10, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression-free Survival (PFS)
Progression-free survival (PFS) is defined as the time from randomization until objective tumor progression (PD) or death. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
18 months
Secondary Outcomes (2)
Overall Survival (OS)
18 months
Objective Response Rate (ORR)
18 months
Study Arms (1)
Paclitaxel/Carboplatin/Everolimus
EXPERIMENTALSystemic Therapy using everolimus, paclitaxel and carboplatin given during a 21-day treatment cycle
Interventions
Paclitaxel, 175mg/m2 by IV infusion over 1-3 hours on day 1 of every 21 day cycle
Carboplatin, AUC 6 given by IV infusion over 20-30 minutes on day 1 of every 21 day cycle
Everolimus, 5 mg by mouth (PO) once a day, continuous dosing every 21-day cycle
Eligibility Criteria
You may qualify if:
- Histologically confirmed metastatic melanoma.
- Stage III or IV disease that is not amenable to resection.
- Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. If the patient has had previous radiation to the target lesion(s), there must be evidence of progression since the radiation.
- ECOG Performance Status of 0 or 1.
- Life expectancy ≥12 weeks.
- No prior cytotoxic chemotherapy or targeted therapy. Immunotherapy is allowed (i.e., interleukin-2 or interferon).
- Adequate hematological function:
- absolute neutrophil count (ANC) ≥1500/µL and
- platelets ≥100,000/µL and
- hemoglobin \>9 g/dL
- Adequate renal function: serum creatinine ≤2.0 mg/dL or calculated (measured) GFR ≥50 mL/min.
- Adequate hepatic function:
- serum bilirubin ≤1.5 x 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.
- Normal PT, INR. Patients on coumadin anticoagulation are eligible if they are on a stable dose, with an INR in the therapeutic range.
- +5 more criteria
You may not qualify if:
- Previous treatment with an mTOR inhibitor (sirolimus, temsirolimus, everolimus), paclitaxel, or carboplatin.
- Treatment with any investigational agent ≤4 weeks of protocol treatment.
- Patients currently receiving anticancer therapies or who have received anticancer therapies ≤3 weeks of the start of the study drug (including radiation therapy, immunotherapy).
- Patients, who have had a major surgery or significant traumatic injury ≤4 weeks of start of study drug or patients who have not recovered from the side effects of any major surgery (defined as requiring general anesthesia).
- Patients receiving chronic, systemic treatment with corticosteroids (dose \>10 mg daily of methylprednisolone or equivalent) or other immunosuppressive agents. Topical or inhaled steroids are allowed.
- Immunization with attenuated live vaccine ≤1 week of study or anytime during study treatment period.
- Patients with active brain metastases are ineligible. Patients with treated brain metastases are eligible if (1) radiation therapy was completed ≥4 weeks prior to study entry; (2) surgery was completed ≥4 weeks prior to study entry; (3) follow-up scan shows no disease progression; and (4) patient does not require steroids.
- Any severe and/or uncontrolled medical conditions or other conditions that could affect participation in the study such as:
- severely impaired lung function defined as a DLCO ≤50% of the normal predicted value and/or O2 saturation ≤88% at rest on room air.
- symptomatic congestive heart failure of New York Heart Association Class III or IV.
- unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction ≤6 months of start of study drug, serious uncontrolled cardiac arrhythmia or any other clinically significant disease.
- uncontrolled diabetes as defined by fasting serum glucose \>1.5 x ULN.
- active (acute or chronic) uncontrolled severe infections.
- liver disease such as cirrhosis, chronic active hepatitis or chronic persistent hepatitis.
- Active, bleeding diathesis.
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- SCRI Development Innovations, LLClead
- Novartiscollaborator
Study Sites (12)
Florida Cancer Specialists
Fort Myers, Florida, 33901, United States
Northeast Georgia Medical Center
Gainesville, Georgia, 30501, United States
Oncology Hematology of SW Indiana
Evansville, Indiana, 47630, United States
Hematology Oncology Clinic, LLP
Baton Rouge, Louisiana, 70809, United States
Center for Cancer and Blood Disorders
Bethesda, Maryland, 20817, United States
Grand Rapids Oncology Program
Grand Rapids, Michigan, 49503, United States
Research Medical Center
Kansas City, Missouri, 64132, United States
Nebraska Methodist Cancer Center
Omaha, Nebraska, 68114, United States
Oncology Hematology Care
Cincinnati, Ohio, 45242, United States
Chattanooga Oncology Hematology Associates
Chattanooga, Tennessee, 37404, United States
Tennessee Oncology, PLLC
Nashville, Tennessee, 37023, United States
Peninsula Cancer Institute
Newport News, Virginia, 23601, United States
Related Publications (1)
Hauke RJ, Infante JR, Rubin MS, Shih KC, Arrowsmith ER, Hainsworth JD. Everolimus in combination with paclitaxel and carboplatin in patients with metastatic melanoma: a phase II trial of the Sarah Cannon Research Institute Oncology Research Consortium. Melanoma Res. 2013 Dec;23(6):468-73. doi: 10.1097/CMR.0000000000000014.
PMID: 23969699RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- John D. Hainsworth, M.D.
- Organization
- SCRI Development Innovations LLC
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
November 16, 2009
First Posted
November 17, 2009
Study Start
February 1, 2010
Primary Completion
February 1, 2012
Study Completion
August 1, 2013
Last Updated
March 26, 2014
Results First Posted
March 26, 2014
Record last verified: 2014-01