Temsirolimus in Combination With Gemcitabine in Previously Untreated Metastatic Pancreatic Cancer

Stopped early · Phase 1

Conditions studied: Pancreatic Adenocarcinoma

In brief

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.

Key facts

Study ID

NCT00593008

Run by

Massachusetts General Hospital

People needed

5

Starts

2007-10-01

Expected to finish

2009-10-01

Last updated by the study team

2011-12-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Previously untreated metastatic pancreatic adenocarcinoma, histologically proven.
• Measurable disease by RECIST criteria
• ECOG Performance Status 0 or 1
• Male or female, 18 years of age or older
• Life expectancy of >/= 12 weeks
• AST and ALT </= 2.5 x ULN
• Total bilirubin </= 1.5 x ULN
• Serum albumin >/= 2.5g/dL
• Absolute neutrophil count >/= 1500/mm3; platelets >/= 100,000/mm3; hemoglobin >/= 9.0 g/dL
• Serum creatinine </= 1.5 x ULN
• Subjects with diabetes must have adequate glycemic control, with fasting serum glucose </= 1.5 x ULN
• Female patients of childbearing age and male patients with partners of childbearing age must agree to use adequate birth control measures during the course of the study and for at least one month following withdrawal from the study

You may not qualify if…

• Previously treatment with gemcitabine or chemoradiation
• Diagnosis of a second malignancy within the last 3 years, except for adequately treated basal cell carcinoma or squamous cell skin cancer
• Ongoing cardiac dysrhythmias of NCI CTCAE grade >/= 2, atrial fibrillation, QTc prolongation to > 450 msec for males and >470 msec for females
• Known immunodeficiency disorders or active infections requiring treatment
• Pregnancy or breastfeeding
• Known brain metastases, spinal cord compression, carcinomatous meningitis, or leptomeningeal disease
• Prior radiation therapy or major surgery within 4 weeks of study entry
• Prior radiation therapy to > 25% of the bone marrow
• Subjects receiving other experimental or alternative therapies during the course of the trial will be excluded
• History of prior hypersensitivity to polysorbate

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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