Advanced Solid Tumors Clinical Trial
Official title:
A Phase I Study of the mTOR Inhibitor Temsirolimus Plus Capecitabine in Patients With Advanced Malignancies
This study is for people with advanced cancer for which no curative treatment exists.
The purpose of this study is to test the safety and effectiveness of the combination of the
drugs Temsirolimus and Capecitabine and see what effects it has on cancer.
Temsirolimus is a drug that is given by vein that targets a protein important for the growth
of cancer cells known as mTOR. By inhibiting this protein, Temsirolimus can inhibit cancer
cell growth and even lead to their death.
Capecitabine is a more traditional chemotherapy. It is an oral pill that gets converted in
the body to the very common chemotherapy known as 5-fluorouracil.
This research is being done because it is not known if the combination of Temsirolimus and
Capecitabine will work better than Capecitabine or Temsirolimus alone.
This is a Phase I study designed to assess the safety and clinical activity of temsirolimus
in combination with capecitabine in patients with advanced malignancies. Because the
toxicities of capecitabine are well established, and based on a previous clinical trial of
temsirolimus and continuous infusion 5-fluorouracil, an alternating dose escalation plan
will be employed.
The first stage of the study will be performed to identify the maximally tolerated dose of
the combination, when capecitabine is given on a every 2 week schedule. The starting dose of
temsirolimus will be 15-mg IV on day 1 and 8 plus capecitabine 1000 mg/m2 by mouth twice a
day on days 1-7 of a 14 day schedule. Patients will be enrolled in a standard 3+3 dose
escalating fashion to a maximum dose of temsirolimus of 25-mg and a maximum dose of
capecitabine of 1750 mg/m2 twice a day.
If the maximally tolerated dose is determined for the every 2 week schedule, then in the
second stage of the study a similar dose escalation plan will be employed for an every 3
week schedule.
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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