A Phase 1 Study of Doxorubicin and A12 in Advanced Soft Tissue Sarcoma
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.
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
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
Maximally tolerated dose (MTD) of cixitumumab when administered in a combination regimen with fixed dose doxorubicin hydrochloride, in patients with locally advanced or metastatic soft tissue sarcoma
The MTD is defined as the dose of Cixitumumab that induces dose-limiting toxicity (DLT) in no more than 20% of patients.
Up to 2 courses of treatment
University of Chicago Comprehensive Cancer Center
United States: Food and Drug Administration
|Loyola University Medical Center||Maywood, Illinois 60153|
|Ingalls Memorial Hospital||Harvey, Illinois 60426|
|Central Illinois Hematology Oncology Center||Springfield, Illinois 62701|
|Decatur Memorial Hospital||Decatur, Illinois 62526|
|University of Chicago Comprehensive Cancer Center||Chicago, Illinois 60637-1470|
|Froedtert and the Medical College of Wisconsin||Milwaukee, Wisconsin 53226|
|Evanston CCOP-NorthShore University HealthSystem||Evanston, Illinois 60201|
|Joliet Oncology-Hematology Associates Limited||Joliet, Illinois 60435|
|Illinois CancerCare-Peoria||Peoria, Illinois 61615|
|Fort Wayne Medical Oncology and Hematology Inc - State Boulevard||Fort Wayne, Indiana 46845|
|Saint John's Mercy Medical Center||Saint Louis, Missouri 63141|
|University of Maryland Greenebaum Cancer Center||Baltimore, Maryland 21201|
|University of Michigan University Hospital||Ann Arbor, Michigan 48109|