Temsirolimus (CCI-770, Torisel) Combined With Cetuximab in Cetuximab-Refractory Colorectal Cancer
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|ClinicalTrials.gov Identifier: NCT00593060|
Recruitment Status : Completed
First Posted : January 14, 2008
Last Update Posted : December 2, 2011
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer Colorectal Adenocarcinoma||Drug: Temsirolimus Drug: Cetuximab||Phase 1|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Trial of Temsirolimus (CCI-779, Torisel) Combined With Cetuximab (Erbitux) in Cetuximab-Refractory Colorectal Cancer|
|Study Start Date :||October 2007|
|Actual Primary Completion Date :||October 2009|
|Actual Study Completion Date :||October 2010|
- To determine the dose-limiting toxicities and maximal tolerated doses of cetuximab combined with temsirolimus. [ Time Frame: 2 years ]
- To determine the dosing regimen appropriate for Phase 2 studies of the combination. [ Time Frame: 2 years ]
- To determine the pharmacokinetics of combined treatment with cetuximab and temsirolimus. [ Time Frame: 2 years ]
- To document objective response rate and progression-free survival in patients treated with the combination. [ Time Frame: 3 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00593060
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Eunice Kwak, MD, PhD||Massachusetts General Hospital|