- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01014351
Study of Everolimus With Paclitaxel and Carboplatin in Patients With Metastatic Melanoma
February 10, 2014 updated by: SCRI Development Innovations, LLC
A Phase II Study of Everolimus in Combination With Paclitaxel and Carboplatin in Patients With Metastatic Melanoma
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
70
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Florida
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Fort Myers, Florida, United States, 33901
- Florida Cancer Specialists
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Georgia
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Gainesville, Georgia, United States, 30501
- Northeast Georgia Medical Center
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Indiana
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Evansville, Indiana, United States, 47630
- Oncology Hematology of SW Indiana
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Louisiana
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Baton Rouge, Louisiana, United States, 70809
- Hematology Oncology Clinic, LLP
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Maryland
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Bethesda, Maryland, United States, 20817
- Center For Cancer And Blood Disorders
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Michigan
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Grand Rapids, Michigan, United States, 49503
- Grand Rapids Oncology Program
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Missouri
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Kansas City, Missouri, United States, 64132
- Research Medical Center
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Nebraska
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Omaha, Nebraska, United States, 68114
- Nebraska Methodist Cancer Center
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Ohio
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Cincinnati, Ohio, United States, 45242
- Oncology Hematology Care
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Tennessee
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Chattanooga, Tennessee, United States, 37404
- Chattanooga Oncology Hematology Associates
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Nashville, Tennessee, United States, 37023
- Tennessee Oncology, PLLC
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Virginia
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Newport News, Virginia, United States, 23601
- Peninsula Cancer Institute
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
- Fasting serum cholesterol ≤300 mg/dL OR ≤7.75 mmol/L AND fasting triglycerides ≤ 2.5 x ULN. NOTE: In case one or both of these thresholds are exceeded, the patient can be included after initiation of appropriate lipid lowering medication.
- Age ≥18 years.
- Ability to swallow whole pills.
- Patient must be accessible for treatment and follow-up.
- Patients must be able to understand the investigational nature of this study and give written informed consent prior to study entry.
Exclusion Criteria:
- 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.
- Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of everolimus (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection).
- A known history of human immunodeficiency virus (HIV) seropositivity.
- Known hypersensitivity to everolimus or other rapamycins (sirolimus, temsirolimus) or to its excipients.
- Use of St. John's Wort is prohibited. Drugs or substances (e.g., grapefruits, star fruits, seville oranges, and their juices and products), known to be inhibitors or inducers of the isoenzyme CYP3A4 should be avoided. Co-administration with substrates, inducers, or inhibitors of P glycoprotein should also be avoided.
- Female patients who are pregnant or breastfeeding or adults of reproductive potential who are not using effective birth control methods. If barrier contraceptives are being used, these must be continued throughout the trial by both sexes. Hormonal contraceptives are not acceptable as a sole method of contraception. (Women of childbearing potential [WOCBP] must have a negative urine or serum pregnancy test within 7 days prior to administration of everolimus.) WOCBP should continue to use effective contraception for 8 weeks after ending everolimus treatment.
- Other malignancies within the past 3 years except for adequately treated carcinoma of the cervix or basal or squamous cell carcinomas of the skin.
- History of noncompliance to medical regimens. Patients unwilling to, or unable to, comply with the protocol.
- History of any other disease, physical examination finding, or clinical laboratory finding that gives reasonable suspicion of a disease or a condition that may render the patient at high risk for treatment complications using these agents.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Paclitaxel/Carboplatin/Everolimus
Systemic Therapy using everolimus, paclitaxel and carboplatin given during a 21-day treatment cycle
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Paclitaxel, 175mg/m2 by IV infusion over 1-3 hours on day 1 of every 21 day cycle
Other Names:
Carboplatin, AUC 6 given by IV infusion over 20-30 minutes on day 1 of every 21 day cycle
Other Names:
Everolimus, 5 mg by mouth (PO) once a day, continuous dosing every 21-day cycle
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression-free Survival (PFS)
Time Frame: 18 months
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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.
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18 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Survival (OS)
Time Frame: 18 months
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Overall survival (OS) is defined as the time from randomization until death from any cause.
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18 months
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Objective Response Rate (ORR)
Time Frame: 18 months
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Objective Response Rate (ORR) is defined as the Percentage of Patients Who Experience an Objective Benefit From Treatment.
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
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18 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Study Chair: John D. Hainsworth, M.D., SCRI Development Innovations, LLC
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2010
Primary Completion (Actual)
February 1, 2012
Study Completion (Actual)
August 1, 2013
Study Registration Dates
First Submitted
November 16, 2009
First Submitted That Met QC Criteria
November 16, 2009
First Posted (Estimate)
November 17, 2009
Study Record Updates
Last Update Posted (Estimate)
March 26, 2014
Last Update Submitted That Met QC Criteria
February 10, 2014
Last Verified
January 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Neuroendocrine Tumors
- Nevi and Melanomas
- Melanoma
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Carboplatin
- Paclitaxel
- Everolimus
Other Study ID Numbers
- SCRI MEL 19
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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