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Status:

COMPLETED

Carboplatin, Paclitaxel, and Bevacizumab With or Without Everolimus in Treating Patients With Metastatic Malignant Melanoma

Lead Sponsor:

Alliance for Clinical Trials in Oncology

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Melanoma (Skin)

Eligibility:

All Genders

18+ years

Phase:

PHASE2

Brief Summary

This randomized phase II trial is studying how well carboplatin, paclitaxel, and bevacizumab work when given with or without everolimus in treating patients with malignant melanoma that has spread fro...

Detailed Description

OBJECTIVES: Primary * To assess whether there is sufficient promise of an impact of the addition of everolimus to the combination of carboplatin, paclitaxel, and bevacizumab on progression-free surv...

Eligibility Criteria

Inclusion

  • Inclusion Criteria:
  • Histologic proof of stage IV malignant melanoma not amenable to surgery; (biopsy can be of locoregional disease in setting of clinically evident stage IV disease, but primary tumor alone will not qualify)
  • At most one prior chemotherapy based regimen for metastatic melanoma (no prior taxane-based regimens allowed); note: prior adjuvant non-taxane based chemotherapy and/or adjuvant immunotherapy are allowed; no limit on the number of prior biologic, immunologic or targeted therapies
  • Measurable disease defined as at least one lesion whose longest diameter can be accurately measured as \>= 2.0 cm with chest x-ray, or as \>= 1.0 cm with computed tomography (CT) scan, CT component of a positron emission tomography (PET)/CT, or magnetic resonance imaging (MRI) scan; note: disease that is measurable by physical examination only is not eligible
  • Life expectancy \>= 4 months
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • Absolute neutrophil count (ANC) \>= 1500/mL
  • Platelets (PLT) \>= 100,000 x 10\^9/L
  • Hemoglobin (Hgb) \>= 9 g/dL (patients may be transfused to meet this requirement)
  • Total cholesterol =\< 300 mg/dL and; (note: serum levels of cholesterol or triglycerides found to be elevated may be lowered with anti-lipid therapy, but must be documented to be below these levels prior to enrollment)
  • Triglycerides =\< 2.5 X upper limit of normal (ULN); (note: serum levels of cholesterol or triglycerides found to be elevated may be lowered with anti-lipid therapy, but must be documented to be below these levels prior to enrollment)
  • Creatinine =\< 1.5 x ULN
  • Total bilirubin =\< 1.5 mg/dL (exception: patients with documented Gilbert's syndrome are allowed to participate despite elevated bilirubin)
  • Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase \[AST\]) =\< 2.5 x ULN
  • Alkaline phosphatase =\< 2.5 x ULN
  • Urine protein:creatinine (UPC) ratio \< 1.0 at screening OR
  • 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 =\< 1 g of protein in 24 hours to be eligible)
  • Negative pregnancy test done =\< 7 days prior to registration/randomization, for women of childbearing potential only
  • Ability to understand and the willingness to sign a written informed consent document
  • Willing to return to a North Central Cancer Treatment Group (NCCTG) institution for follow-up
  • Willing to provide mandatory blood samples for research purposes
  • Willing to follow a diet low in fat and cholesterol while taking everolimus
  • Willing to abstain from eating grapefruit or drinking grapefruit juice for the duration of the study
  • Exclusion Criteria
  • Prior treatment with agents disrupting vascular endothelial growth factor (VEGF) activity (i.e., bevacizumab, VEGF-trap, anti-VEGF receptor \[R\] monoclonal antibody \[Mab\]) or targeting VEGFR (e.g. sunitinib, sorafenib)
  • Prior treatment with an mTOR inhibitor for melanoma (sirolimus, temsirolimus, everolimus)
  • Brain metastases per MRI or CT at any time prior to registration; note: patients that have had primary therapy for brain metastasis (i.e. surgical resection, whole brain radiation, or stereotactic radiation therapy \[SRT\] even if stable) are not eligible
  • Other investigational agents =\< 4 weeks prior to registration/randomization
  • Chemotherapy treatment =\< 3 weeks prior to registration/randomization
  • Any biologic, immunologic or targeted therapy =\< 2 weeks prior to registration/randomization
  • Major surgical procedure, open biopsy, or significant traumatic injury =\< 4 weeks prior to registration/randomization
  • Fine needle aspirations or core biopsies =\< 7 days prior to registration/randomization
  • Planned/or anticipated major surgical procedure during the course of the study
  • Other medical conditions including but not limited to:
  • History of liver disease such as cirrhosis, chronic active hepatitis, chronic persistent hepatitis or hepatitis B or C
  • Active infection requiring parenteral antibiotics
  • Poorly controlled high blood pressure (\>=150 mm Hg systolic and/or 100 mmHg diastolic) despite treatment
  • New York Heart Association class II-IV congestive heart failure
  • Serious cardiac arrhythmia requiring medication
  • Myocardial infarction or unstable angina =\< 6 months prior to registration/randomization
  • Clinically significant peripheral vascular disease
  • Deep venous thrombosis or pulmonary embolus =\< 1 year of registration/randomization and/or ongoing need for full-dose oral or parenteral anticoagulation
  • Ongoing anti-platelet treatment other than low-dose aspirin (i.e., aspirin 81 mg orally \[p.o.\] daily)
  • Active bleeding or pathological conditions that carry high risk of bleeding (e.g., known esophageal varices, etc.)
  • Serious, non-healing wound (including wounds healing by secondary intention), ulcer or bone fracture
  • History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess =\< 6 months prior to registration/randomization
  • History of central nervous system (CNS) disease (e.g., primary brain tumor, vascular abnormalities, etc.), clinically significant stroke or transient ischemic attack (TIA) =\< 6 months prior to registration/randomization, seizures not controlled with standard medical therapy
  • Radiographically documented tumor invading major blood vessels
  • History of hypertensive crisis or hypertensive encephalopathy
  • Uncontrolled diabetes as defined by fasting serum glucose \> 1.5 x ULN
  • Severely impaired lung function as defined as spirometry and diffusing capacity of the lung for carbon monoxide (DLCO) that is 50% of the normal predicted value and/or 02 saturation that is 88% or less at rest on room air
  • A known history of human immunodeficiency virus (HIV) seropositivity
  • Any of the following as this regimen may be harmful to a developing fetus or nursing child:
  • Pregnant women
  • Nursing women
  • Men and women of reproductive potential who are not using effective birth control methods must use highly effective contraception throughout the trail and for 6 months after last study treatment
  • Existence of peripheral sensory neuropathy \>= grade 2
  • History of other malignancy =\< 5 years with the exception of basal cell or squamous cell carcinoma of the skin, treated with local resection only, or carcinoma in situ (e.g. of the cervix, breast, prostate, etc.)
  • =\< 4 weeks since last day of adjuvant radiation therapy prior to registration or =\< 2 weeks since last day of palliative radiation therapy; NOTE: patients who have had \> 25% of their functional bone marrow irradiated are not eligible for this trial
  • Active or recent history of hemoptysis (\>= 1/2 teaspoon of bright red blood per episode) =\< 30 days prior to registration
  • Known hypersensitivity to any of the components of the everolimus, bevacizumab, carboplatin, or paclitaxel
  • Current use of drugs that are known to be strong inhibitors or inducers of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4); note: if these agents are discontinued, everolimus therapy can begin \>= 7 days after discontinuation of such agent
  • Positive hepatitis B antigen (HBsAg) or hepatitis C serology (HCV) tests
  • Planned immunization with attenuated live vaccines =\< 7 days prior to registration or during study period; note: close contact with those who have received attenuated live vaccines should be avoided during treatment with everolimus; examples of live vaccines include intranasal influenza, measles, mumps, rubella, oral polio, Bacillus Calmette-Guérin (BCG), yellow fever, varicella and TY21a typhoid vaccines

Exclusion

    Key Trial Info

    Start Date :

    April 1 2010

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    September 1 2015

    Estimated Enrollment :

    149 Patients enrolled

    Trial Details

    Trial ID

    NCT00976573

    Start Date

    April 1 2010

    End Date

    September 1 2015

    Last Update

    April 4 2017

    Active Locations (310)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 78 (310 locations)

    1

    Mayo Clinic Scottsdale

    Scottsdale, Arizona, United States, 85259-5499

    2

    Contra Costa Regional Medical Center

    Martinez, California, United States, 94553-3156

    3

    El Camino Hospital Cancer Center

    Mountain View, California, United States, 94040

    4

    Bay Area Breast Surgeons, Incorporated

    Oakland, California, United States, 94609