Temsirolimus in Combination With Gemcitabine in Previously Untreated Metastatic Pancreatic Cancer
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|ClinicalTrials.gov Identifier: NCT00593008|
Recruitment Status : Terminated
First Posted : January 14, 2008
Last Update Posted : December 2, 2011
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Adenocarcinoma||Drug: Temsirolimus Drug: Gemcitabine||Phase 1|
- Because this is a study to determine the highest doses of temsirolimus and gemcitabine that can be given safely together, groups of 3 subjects will be treated at gradually increasing doses of the drugs. Each group of 3 subjects must complete 4 weeks of treatment (1 cycle) before the following group of 3 subjects can start treatment at the higher dose of drug.
- Temsirolimus will be given intravenously every week of the 28 day treatment cycle (days 1, 8, 15, 22). Gemcitabine will be given intravenously every other week of the treatment cycle (days 1. 15).
- During the study, participants will have weekly clinic visits where the following tests and procedures may be performed: Physical exam; vital signs; urine test; blood tests.
- A CT scan will be performed after every 2 cycles (8 weeks) to assess teh response of the tumor to the study treatment.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1 Study of Temsirolimus in Combination With Gemcitabine in Previously Untreated Metastatic Pancreatic Cancer|
|Study Start Date :||October 2007|
|Actual Primary Completion Date :||October 2009|
|Actual Study Completion Date :||October 2009|
- To determine the dose-limiting toxicities and maximal tolerated doses of gemcitabine combined with temsirolimus [ Time Frame: 2 years ]
- To determine whether order of administration of the drugs affects the above [ Time Frame: 2 years ]
- To determine the dosing regimen appropriate for Phase 2 studies of the combination [ Time Frame: 2 years ]
- To document objective response rate and progression-free survival in patients treated with this combination
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): NCT00593008
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02215|
|Principal Investigator:||Eunice Kwak, MD, PhD||Massachusetts General Hospital|