A Phase 1 Study of Temsirolimus in Combination With Gemcitabine in Previously Untreated Metastatic Pancreatic Cancer
- 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.
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 gemcitabine combined with temsirolimus
Eunice Kwak, MD, PhD
Massachusetts General Hospital
United States: Food and Drug Administration
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|