Finding studies
Finding studies
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Lead
M.D. Anderson Cancer Center
With
PRIMARY OBJECTIVES: I. To define the maximum tolerated doses (MTD) of two established chemotherapy regimens (Arm A: FOLFOX6 \[oxaliplatin, fluorouracil (5FU) and leucovorin (folinic acid)\] plus bevacizumab; and Arm B: pegylated liposomal doxorubicin hydrochloride \[liposomal doxorubicin\] and bevacizumab plus temsirolimus \[DAT\]) in combination with the concurrent use of the NovoTTF-100L(P) system in patients with predominant hepatic metastases. II. To define the safety profiles of FOLFOX6 plus bevacizumab or DAT with concurrent NovoTTF-100L(P) in patients with predominant hepatic metastases. SECONDARY OBJECTIVES: I. To evaluate clinical response signals to the treatment with FOLFOX6 plus bevacizumab or DAT with concurrent NovoTTF-100L(P). II. To assess predictive biomarkers by analyzing baseline molecular mutation status, and resistant pathways by comparing molecular signatures at baseline versus at time of relapse in patients who have achieved objective responses. OUTLINE: This is a dose-escalation study. Participants are assigned to 1 of 2 arms. ARM A: Participants receive oxaliplatin, leucovorin, and fluorouracil via pump over 46 hours beginning on day 1, bevacizumab intravenously (IV) over 30-90 minutes on days 1 and 15, and use NovoTTF-100L(P) system over 18 hours daily. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. ARM B: Participants receive bevacizumab IV over 90 minutes on days 1 and 15, pegylated liposomal doxorubicin hydrochloride IV over 30 minutes-3 hours on days 1 and 15, and temsirolimus IV over 60-90 minutes on days 1, 8, 15, and 22. Participants also use NovoTTF-100L(P) system over 18 hours daily. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After the completion of study treatment, patients are followed at 30 days.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
