Carboplatin, Paclitaxel, and Bevacizumab With or Without Everolimus in Treating Patients With Metastatic Malignant Melanoma
Location:
Rochester, Minn., Jacksonville, Fla.
Trial status:
Open for Enrollment
Why is this study being done?
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 survival that it would be recommended for further testing in patients with metastatic malignant melanoma.
Secondary
- 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 regimens.
- 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 therapy.
- 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 toxicity.
- 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 years.
NCT ID:
NCT00976573
IRB Number:
09-005838
Who can I contact for additional information about this study?
Rochester: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623
Scottsdale: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623
Jacksonville: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623