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

Completed · Phase 2

Conditions studied: Melanoma (Skin)

In brief

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 from where it started to other places in the body. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, may block the ability of tumor cells to grow and spread. Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. It is not yet known whether combination chemotherapy given together with bevacizumab is more effective with or without everolimus in treating patients with metastatic melanoma.

Key facts

Study ID

NCT00976573

Run by

Alliance for Clinical Trials in Oncology

People needed

149

Starts

2010-04-01

Expected to finish

2015-09-01

Last updated by the study team

2017-04-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Contra Costa Regional Medical Center — Martinez, California, United States
• El Camino Hospital Cancer Center — Mountain View, California, United States
• Bay Area Breast Surgeons, Incorporated — Oakland, California, United States
• CCOP - Bay Area Tumor Institute — Oakland, California, United States
• Larry G Strieff MD Medical Corporation — Oakland, California, United States
• Tom K Lee, Incorporated — Oakland, California, United States
• Doctors Medical Center - San Pablo Campus — San Pablo, California, United States
• Aurora Presbyterian Hospital — Aurora, Colorado, United States
• Boulder Community Hospital — Boulder, Colorado, United States
• Penrose Cancer Center at Penrose Hospital — Colorado Springs, Colorado, United States
• St. Anthony Central Hospital — Denver, Colorado, United States
• Porter Adventist Hospital — Denver, Colorado, United States
• Presbyterian - St. Luke's Medical Center — Denver, Colorado, United States
• St. Joseph Hospital — Denver, Colorado, United States
• Rose Medical Center — Denver, Colorado, United States
• Swedish Medical Center — Englewood, Colorado, United States
• Poudre Valley Hospital — Fort Collins, Colorado, United States
• Front Range Cancer Specialists — Fort Collins, Colorado, United States
• North Colorado Medical Center — Greeley, Colorado, United States
• Sky Ridge Medical Center — Lone Tree, Colorado, United States
• Hope Cancer Care Center at Longmont United Hospital — Longmont, Colorado, United States
• McKee Medical Center — Loveland, Colorado, United States
• St. Mary - Corwin Regional Medical Center — Pueblo, Colorado, United States
• North Suburban Medical Center — Thornton, Colorado, United States
• Mayo Clinic Scottsdale — Scottsdale, Arizona, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.