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A Randomized Phase II Trial of Carboplatin, Paclitaxel, Bevacizumab, With or Without Everolimus for Therapy of Metastatic Malignant Melanoma

Phase 2
18 Years
Open (Enrolling)
Melanoma (Skin)

Thank you

Trial Information

A Randomized Phase II Trial of Carboplatin, Paclitaxel, Bevacizumab, With or Without Everolimus for Therapy of Metastatic Malignant Melanoma



- 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 survival that it would be recommended for further testing in patients
with metastatic malignant melanoma.


- Estimate the confirmed tumor response rate in patients treated with carboplatin,
paclitaxel, and bevacizumab with or without everolimus.

- Estimate the distribution of overall survival time in patients treated with these

- Assess the safety profile of these regimens in these patients.

- Examine the impact of therapy on angiogenesis and immune homeostasis.

- Assess common genetic variants in mTOR and associated genes that may impact response to

- Collect circulating tumor cells in a valid and reproducible way and assess target
marker expression using immunofluorescence and reverse transcriptase-PCR.

OUTLINE: This is a multicenter study. Patients are stratified according to elevated LDH
(above upper limit of normal) at baseline (yes vs no), location of metastatic disease (M1a
[skin, subcutaneous tissue, or lymph node only] vs M1b [lung] vs M1c [other visceral sites])
and prior chemotherapy for metastatic disease (yes vs no). Patients are randomized to 1 of 2
treatment arms.

- Arm I: Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15, paclitaxel
IV over 60 minutes on days 1, 8, and 15, and carboplatin IV over 30 minutes on day 1.
Courses repeat every 28 days in the absence of disease progression or unacceptable

- Arm II: Patients receive bevacizumab, paclitaxel, and carboplatin as in arm I. Patients
also receive oral everolimus on 3 days a week. Courses repeat every 28 days in the
absence of disease progression or unacceptable toxicity.

Blood samples are collected at baseline and periodically during study for analysis of plasma
VEGF levels by ELISA; changes in immune homeostasis by immunophenotyping, tetramer assay,
and ELISPOT assay; and analysis of genetic variants in mTOR and associated genes by
polymorphism studies.

After completion of study therapy, patients are followed up every 3-6 months for up to 5

Inclusion Criteria


- Histologically* confirmed malignant melanoma

- Stage IV disease

- Not amenable to surgery

- NOTE: *Biopsy may be of locoregional disease in the setting of clinically evident
stage IV disease, but primary tumor alone will not qualify

- Measurable disease, defined as ≥ 1 lesion whose longest diameter can be accurately
measured as ≥ 2.0 cm by chest x-ray OR as ≥ 1.0 cm by CT scan, CT component of a
PET/CT scan, or MRI scan

- No disease measurable by physical examination only

- No radiographically documented tumor invading major blood vessels

- No primary brain tumor or brain metastases by MRI or CT scan

- Patients who have had primary therapy for brain metastases (e.g., surgical
resection, whole brain radiotherapy, or stereotactic radiotherapy) are not
eligible, even if the metastases are stable


- ECOG performance status 0-1

- Life expectancy ≥ 4 months

- ANC ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

- Hemoglobin ≥ 9 g/dL (transfusion allowed)

- Total cholesterol ≤ 300 mg/dL AND triglycerides ≤ 2.5 times upper limit of normal

- Anti-lipid therapy to lower elevated serum levels of cholesterol or
triglycerides allowed

- Total bilirubin ≤ 1.5 mg/dL (elevated bilirubin levels allowed in patients with
documented Gilbert's syndrome)

- SGOT ≤ 2.5 times ULN

- Alkaline phosphatase ≤ 2.5 times ULN

- Creatinine ≤ 1.5 times ULN

- Urine protein:creatinine ratio < 1.0 OR proteinuria < 2+ by urine dipstick OR ≤ 1g of
protein by 24-hour urine collection

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 8 weeks after
completion of study therapy

- Hormonal contraceptives are not acceptable as a sole method of contraception

- Willing to provide mandatory blood samples for research purposes

- Willing to follow a diet low in fat and cholesterol while taking everolimus

- No other medical condition including, but not limited to, the following:

- History of liver disease (e.g., cirrhosis, chronic active hepatitis, chronic
persistent hepatitis, or hepatitis B or C [positive hepatitis B antigen or
hepatitis C serology])

- Active infection requiring parenteral antibiotics

- Poorly controlled high BP (i.e., systolic BP ≥ 150 mm Hg and/or diastolic BP ≥
100 mm Hg) despite treatment

- NYHA class II-IV congestive heart failure

- Serious cardiac arrhythmia requiring medication

- Myocardial infarction or unstable angina within the past 6 months

- Clinically significant peripheral vascular disease

- Deep venous thrombosis or pulmonary embolus within the past year

- Active bleeding or pathological condition that carries a high risk of bleeding
(e.g., known esophageal varices)

- Serious, non-healing wound (including wounds healing by secondary intention),
ulcer, or bone fracture

- Abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess
within the past 6 months

- History of CNS disease (e.g., vascular abnormalities), clinically significant
stroke or TIA within the past 6 months, or seizures not controlled with standard
medical therapy

- History of hypertensive crisis or hypertensive encephalopathy

- Uncontrolled diabetes, defined as fasting serum glucose > 1.5 times ULN

- Severely impaired lung function, defined as DLCO that is 50% of the normal
predicted value and/or 0_2 saturation ≤ 88% at rest on room air

- Known history of HIV seropositivity

- No peripheral sensory neuropathy ≥ grade 2

- No other malignancy within the past 5 years except basal cell or squamous cell
carcinoma of the skin treated with local resection or curatively treated carcinoma in
situ (e.g., of the cervix, breast, prostate, etc.)

- No active hemoptysis (≥ ½ teaspoon of bright red blood per episode) within the past
30 days

- No significant traumatic injury within the past 4 weeks

- No known hypersensitivity to any of the components of everolimus, bevacizumab,
carboplatin, or paclitaxel


- No more than one prior chemotherapy-based regimen for metastatic melanoma

- No prior taxane-based regimens

- Prior adjuvant non-taxane-based chemotherapy and/or adjuvant immunotherapy

- Any number of prior biologic, immunologic, or targeted therapies allowed

- More than 2 weeks since any prior biologic, immunologic, or targeted

- More than 3 weeks since prior chemotherapy

- At least 7 days since prior and no concurrent drugs that are known to be strong
inhibitors or inducers of CYP3A4

- More than 4 weeks since prior investigational agents

- More than 4 weeks since prior major surgical procedure or open biopsy

- More than 7 days since prior fine needle aspiration or core biopsy

- More than 4 weeks since prior adjuvant radiotherapy

- More than 2 weeks since prior palliative radiotherapy

- No prior radiotherapy to > 25% of the functioning bone marrow

- No prior treatment with agents disrupting VEGF activity (e.g., bevacizumab,
aflibercept, or anti-VEGFR monoclonal antibody) or targeting VEGFR (e.g., sunitinib
malate or sorafenib tosylate)

- No prior mTOR inhibitors (e.g., sirolimus, temsirolimus, or everolimus) for melanoma

- No concurrent major surgical procedure

- No concurrent anti-platelet therapy other than low-dose aspirin (i.e., 81 mg of
aspirin 81 daily)

- No concurrent full-dose oral or parenteral anticoagulation or prophylactic

- No concurrent grapefruit or grapefruit juice

- No concurrent radiotherapy

- No other concurrent chemotherapy

- No concurrent enrollment in another clinical trial involving investigational
procedures or agents to treat the primary malignancy

- No planned immunization with attenuated live vaccines ≤ 7 days

Type of Study:


Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival

Safety Issue:


Principal Investigator

Robert McWilliams, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic



Study ID:




Start Date:

April 2010

Completion Date:

Related Keywords:

  • Melanoma (Skin)
  • stage IV melanoma
  • recurrent melanoma
  • Melanoma



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