A Randomized, Phase II ECOG Trial of Two Dose Levels of CCI-779 in Patients With Extensive-Stage Small Cell Lung Cancer Who Have Responding or Stable Disease After Induction Chemotherapy
I. To study the progression-free survival in patients who receive a lower or a higher dose
of CCI-779, a cytostatic agent following cytoreductive chemotherapy in extensive SCLC.
II. To determine the toxicity of two treatment regimens involving a lower or a higher dose
I. To quantify the effects of CCI-779 treatment on p70S6 phosphorylation in peripheral blood
mononuclear cells of patients with small cell lung cancer who are treated with CCI-779.
II. To measure the effects on mTOR activation and signaling of plasma from patients treated
III. To determine the relationship between CCI-779 dose and its pharmacodynamic parameters.
IV. To correlate the inhibition of p70S6 with indices of patient outcome.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to brain
metastases (yes vs no), prior induction chemotherapy regimen (platinum and etoposide vs
platinum and irinotecan), and response to prior induction chemotherapy (complete or partial
response vs stable disease). Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive low-dose CCI-779 IV over 30 minutes once weekly. Treatment continues
in the absence of disease progression or unacceptable toxicity.
ARM II: Patients receive high-dose CCI-779 as in arm I.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression-free survival (PFS)
A log-rank test will compare the PFS curves of both arms.
Time to death or relapse, assessed up to 6 years
Eastern Cooperative Oncology Group
United States: Food and Drug Administration
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