Recurrent Adult Soft Tissue Sarcoma Clinical Trial
Official title:
A Phase 1 Study of Doxorubicin and A12 in Advanced Soft Tissue Sarcoma
This phase I trial is studying the side effects and best dose of cixutumumab given together with doxorubicin hydrochloride and to see how well they work in treating patients with unresectable, locally advanced, or metastatic soft tissue sarcoma. Monoclonal antibodies, such as cixutumumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as doxorubicin hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving monoclonal antibody cixutumumab together with doxorubicin hydrochloride may kill more tumor cells.
PRIMARY OBJECTIVES:
I. To collect safety data about the combination of doxorubicin and Cixitumumab and determine
if they can be combined with acceptable toxicity at full doses.
SECONDARY OBJECTIVES:
I. To assess the confirmed response rate (CR + PR as defined by RECIST) of patients with
locally advanced or metastatic soft tissue sarcoma when treated with combination doxorubicin
and Cixitumumab II. To assess the 3 and 6 month progression free survival rate of patients
treated with doxorubicin and Cixitumumab.
III. To assess the progression free survival and overall survival of patients treated with
doxorubicin and Cixitumumab.
IV. To evaluate changes in left ventricular ejection fraction assessed by MUGA scan after 2,
4 and 6 cycles of therapy compared to baseline.
OUTLINE: This is a multicenter, dose-escalation study of anti-IGF-1R recombinant monoclonal
antibody cixutumumab.
Patients receive cixutumumab intravenously (IV) over 1 hour on days 1, 8, and 15 and
doxorubicin hydrochloride IV continuously over 44-52 hours beginning on day 1. Treatment
repeats every 21 days for up to 6 courses in the absence of disease progression or
unacceptable toxicity. Patients with stable or responding disease may continue to receive
cixutumumab in the absence of disease progression or unacceptable toxicity.
;
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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