A Phase 2 Study of Temsirolimus (CCI-779, NSC 683864) and IGF-1 Receptor Antibody Cixutumumab (IMC-A12, NSC 742460) in Patients With Metastatic Sarcomas
PRIMARY OBJECTIVES:
I. To determine the proportion of patients progression-free at 12 weeks (PFS, defined as
RECIST 1.1 CR + PR + SD) with (A) IGF-1R+ soft tissue sarcomas; (B) IGF-1R+ bone tumors; or
(C) IGF-1R(-) sarcomas, who are treated weekly with intravenous A12 and temsirolimus.
SECONDARY OBJECTIVES:
I. To determine the overall response rate (defined as complete response [CR] + partial
response [PR]).
II. To determine the overall survival. III. To determine the correlation of clinical outcome
with pre- and post-treatment IGF-1R pathway related markers in plasma (pre and post
therapy), archived tissue, and pre- and post-treatment tumor biopsies.
OUTLINE:
Patients receive cixutumumab IV over 60 minutes and temsirolimus IV over 30 minutes on days
1, 8, 15, 22, 29, and 36. Courses repeat every 42 days in the absence of disease progression
or unacceptable toxicity.
After completion of study treatment, patients are followed up for ≥ 4 weeks.
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression-free survival rate, defined as CR + PR + SD, as assessed by RECIST criteria
For each arm, the response rate will be estimated and a confidence interval will be constructed.
12 weeks
No
Gary Schwartz
Principal Investigator
Memorial Sloan-Kettering Cancer Center
United States: Food and Drug Administration
NCI-2011-01408
NCT01016015
November 2009
Name | Location |
---|---|
Memorial Sloan Kettering Cancer Center | New York, New York 10021 |
M D Anderson Cancer Center | Houston, Texas 77030 |