Temsirolimus in Combination With Gemcitabine in Previously Untreated Metastatic Pancreatic Cancer
NCT ID: NCT00593008
Last Updated: 2011-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
5 participants
INTERVENTIONAL
2007-10-31
2009-10-31
Brief Summary
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Detailed Description
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* 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
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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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.
Gemcitabine
Given intravenously every other week of each 28-day cycle.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Brigham and Women's Hospital
OTHER
Dana-Farber Cancer Institute
OTHER
Wyeth is now a wholly owned subsidiary of Pfizer
INDUSTRY
Massachusetts General Hospital
OTHER
Responsible Party
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Eunice L. Kwak, MD, PhD
Assistant in Medicine
Principal Investigators
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Eunice Kwak, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Locations
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Massachusetts General Hospital
Boston, Massachusetts, United States
Countries
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Other Identifiers
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07-115
Identifier Type: -
Identifier Source: org_study_id