Colon Cancer Clinical Trial
Official title:
A Randomized Placebo-Controlled Study of Perifosine in Combination With Single Agent Chemotherapy for Metastatic Cancer Patients
This is an exploratory phase 2, randomized placebo-controlled trial with stratification for
disease and chemotherapy type. The study is subsequently closed to enrollment in all arms
except patients with metastatic colorectal cancer which would be randomized to either
capecitabine plus perifosine or capecitabine alone.
The effects of perifosine may be manifested by increased time to progression, tumor
regression reflected in partial or complete responses, or a combination of these outcomes.
The primary goal of this trial is to obtain a preliminary and objective assessment of the
effects of perifosine on time to progression.
This is an exploratory phase 2, randomized placebo-controlled trial with stratification for
disease and chemotherapy type. If there is any evidence of improved time to progression in
any tumor type with any of the drugs to be evaluated, the initial study or component(s) of
the study will be expanded to increase the certainty that this is an effect of perifosine. If
there is compelling evidence of benefit from this study, a phase 3 trial will be conducted to
obtain proof of principle.
Primary Study Objectives:
To determine the time to tumor progression when receiving single agent chemotherapy
(capecitabine) in combination with perifosine in comparison to patients receiving single
agent chemotherapy (capecitabine) alone (i.e., with placebo).
Secondary Study Objectives:
- To determine the toxicity of single agent chemotherapy in combination with perifosine.
- To compare the time to progression of chemotherapy in combination with placebo to
historical experience.
- Overall survival will also be evaluated.
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