Clinical trialPhase 1Terminated
Temsirolimus in Combination With Gemcitabine in Previously Untreated Metastatic Pancreatic Cancer
A Phase 1 Study of Temsirolimus in Combination With Gemcitabine in Previously Untreated Metastatic Pancreatic Cancer
- Outcome
- Stopped early
- Phase
- Phase 1
- Status
- Terminated
- Study type
- Interventional
- Start
- October 2007
- Expected end
- October 2009
- Enrollment
- 5 participants
- Sites
- 1
- Primary outcomes
- To determine the dose-limiting toxicities and maximal tolerated doses of gemcitabine combined with temsirolimus; To determine whether order of administration of the drugs affects the above; To determine the dosing regimen appropriate for Phase 2 studies of the combination
- Sponsor
- Other
- Results posted
- No
- Last update
- 2 December 2011
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Brief summary public domain (ClinicalTrials.gov)
The purpose of this research study is to try to define the highest doses of temsirolimus and gemcitabine that can be used safely in combination to treat advanced pancreatic cancer. Gemcitabine is a standard chemotherapy used for the treatment of pancreatic cancer.
Detailed description public domain (ClinicalTrials.gov)
* 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.