A Trial of CCI-779 in Patients With Soft Tissue Sarcoma.
I. To assess the antitumor activity of CCI-779 in this patient population.
I. To assess the following in patients with soft tissue sarcomas and following treatment
with CCI-779: duration of response, time to progression, survival.
I. To describe and correlate the following with patient characteristics and outcome in this
patient population and following treatment with CCI-779: relative levels of 4EBP1 to eIF4E,
phospho 4EBP1, total and phospho ribosomal S6 on pretreatment tumor tissue, expression
levels of EGFR, activated EGFR, Her2, c-Myc, phospho Akt, total Akt, phospho-mTOR and total
mTOR on pretreatment tumor tissue, drug induced inhibition of p70S6 kinase activity, and
phosphorylation of S6 in PBMC, relative levels of serum sirolimus in post-treatment samples.
Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every
28 days in the absence of disease progression or unacceptable toxicity. Patients achieving a
complete response (CR) receive 2 additional courses beyond CR.
Patients are followed every 3 months for 1 year, every 4 months for 1 year, and then every 6
months for 3 years.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Proportion of confirmed tumor responses, defined to be either a CR or PR noted as the objective status on 2 consecutive evaluations at least 4 weeks apart
Up to 6 months (6 courses)
United States: Food and Drug Administration
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