A Phase I Trial of Temsirolimus (CCI-779, Torisel) Combined With Cetuximab (Erbitux) in Cetuximab-Refractory Colorectal Cancer
- Because this is a study to determine the highest dose of cetuximab that can be safely
given with temsirolimus, groups of 3 participants will be treated at gradually
increasing doses of cetuximab. Each group of 3 participants must complete 4 weeks (1
cycle) of treatment before the following group of 3 participants can start treatment at
the higher dose.
- Cetuximab is administered intravenously 7 days before the treatment cycle begins.
Participants will receive a cetuximab infusion every week of the treatment cycle (days
1, 8, 15, 22) along with temsirolimus. Temsirolimus is also given intravenously.
- As a precaution, participants will be pre-medicated with Benadryl/diphenhydramine to
help prevent an allergic reaction.
- During the study participants will have weekly clinical visits. Each clinic visit will
last approximately 2-3 hours. During the clinic visit, the following tests and
procedures will be performed: Physical exam; vital signs; and blood tests. A CT scan
will be performed after every 2 cycles (8 weeks).
- Pharmacokinetic (PK) blood samples will be taken at various points during the study.
For each PK sample, we will take about 1 teaspoon of blood. There will be a total of
22 tubes of blood taken for the PK study.
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the dose-limiting toxicities and maximal tolerated doses of cetuximab combined with temsirolimus.
Eunice Kwak, MD, PhD
Massachusetts General Hospital
United States: Food and Drug Administration
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|