NCT00593008

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

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

* 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.

Conditions

• Pancreatic Adenocarcinoma

Interventions

Type	Name	Description
DRUG	Temsirolimus	Given intravenously every week of each 28-day cycle (days 1, 8, 15 and 22). Participants may continue to receive study treatment as long as their tumor is responding and they don't experience any serious side effects.
DRUG	Gemcitabine	Given intravenously every other week of each 28-day cycle.

Timeline

• Start date: 2007-10-01
• Primary completion: 2009-10-01
• Completion: 2009-10-01
• First posted: 2008-01-14
• Last updated: 2011-12-02

Locations

1 site across 1 country: United States