Carcinoma, Non-Small-Cell Lung Clinical Trial
Official title:
A Phase I/II Trial of Temsirolimus and Pemetrexed in Recurrent/Refractory Non Small Cell Lung Cancer (NSCLC)
To determine the maximum tolerated dose (MTD) and dose limiting toxicities (DLT) of the combination of temsirolimus and pemetrexed, as well as the response rate.
- To determine the maximum tolerated dose (MTD) of temsirolimus that could be
administered weekly in combination with pemetrexed.
- To determine the dose-limiting toxicity (DLT) of temsirolimus and pemetrexed as well as
other toxicities of this combination therapy.
- To describe the response rate of the combination in patients with relapsed/refractory
non-small cell lung cancer (NSCLC).
- To describe phospho-Akt and phospho-S6 levels in circulating mononuclear cells before
and after treatment.
- To determine the response rates in patients with NSCLC when treated with temsirolimus
and pemetrexed.
- To evaluate progression-free survival in patients with NSCLC when treated with
temsirolimus and pemetrexed.
- To determine the one-year survival rates in patients with NSCLC when treated with
temsirolimus and pemetrexed.
- To describe phospho-Akt and phospho-S6 levels in circulating mononuclear cells before
and after treatment.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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