Temsirolimus In Combination With Gemcitabine In Previously Untreated Metastatic Pancreatic Cancer

Study Overview

Temsirolimus in Combination With Gemcitabine in Previously Untreated Metastatic Pancreatic Cancer

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.

* 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.

Pancreatic Adenocarcinoma

DRUG: Temsirolimus
DRUG: Gemcitabine

07-115

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2007-12-28	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2011-12-01
First Submitted that Met QC Criteria 2008-01-11	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2011-12-02
First Posted (ESTIMATED) 2008-01-14	Results First Posted N/A	Last Verified 2011-12

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Non Randomized

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment

Primary Outcome Measures	Measure Description	Time Frame
To determine the dose-limiting toxicities and maximal tolerated doses of gemcitabine combined with temsirolimus		2 years
To determine whether order of administration of the drugs affects the above		2 years
To determine the dosing regimen appropriate for Phase 2 studies of the combination		2 years

Secondary Outcome Measures	Measure Description	Time Frame
To document objective response rate and progression-free survival in patients treated with this combination

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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
Total bilirubin
Serum albumin >/= 2.5g/dL
Absolute neutrophil count >/= 1500/mm3; platelets >/= 100,000/mm3; hemoglobin >/= 9.0 g/dL
Serum creatinine
Subjects with diabetes must have adequate glycemic control, with fasting serum glucose
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
History of prior hypersensitivity to polysorbate

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Brigham and Women's Hospital
Dana-Farber Cancer Institute
Wyeth is now a wholly owned subsidiary of Pfizer

Investigators

PRINCIPAL_INVESTIGATOR: Eunice Kwak, MD, PhD, Massachusetts General Hospital

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

Learn

Resources

PatientS

Caregivers

Clinical Trial Record