Temsirolimus in Combination With Gemcitabine in Previously Untreated Metastatic Pancreatic Cancer
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ClinicalTrials.gov Identifier: NCT00593008
Recruitment Status :
First Posted : January 14, 2008
Last Update Posted : December 2, 2011
Massachusetts General Hospital
Brigham and Women's Hospital
Dana-Farber Cancer Institute
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by (Responsible Party):
Eunice L. Kwak, MD, PhD, Massachusetts General Hospital
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.
Condition or disease
Drug: TemsirolimusDrug: Gemcitabine
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.
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.
Given intravenously every other week of each 28-day cycle.
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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
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
Keywords provided by Eunice L. Kwak, MD, PhD, Massachusetts General Hospital:
metastatic pancreatic cancer
Additional relevant MeSH terms:
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Endocrine System Diseases