- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00593008
Temsirolimus in Combination With Gemcitabine in Previously Untreated Metastatic Pancreatic Cancer
December 1, 2011 updated by: Eunice L. Kwak, MD, PhD, Massachusetts General Hospital
A Phase 1 Study of 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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
5
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Massachusetts
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Boston, Massachusetts, United States, 02215
- Massachusetts General Hospital
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-
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.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To determine the dose-limiting toxicities and maximal tolerated doses of gemcitabine combined with temsirolimus
Time Frame: 2 years
|
2 years
|
To determine whether order of administration of the drugs affects the above
Time Frame: 2 years
|
2 years
|
To determine the dosing regimen appropriate for Phase 2 studies of the combination
Time Frame: 2 years
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
---|
To document objective response rate and progression-free survival in patients treated with this combination
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Eunice Kwak, MD, PhD, Massachusetts General Hospital
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 Major Dates
Study Start
October 1, 2007
Primary Completion (Actual)
October 1, 2009
Study Completion (Actual)
October 1, 2009
Study Registration Dates
First Submitted
December 28, 2007
First Submitted That Met QC Criteria
January 11, 2008
First Posted (Estimate)
January 14, 2008
Study Record Updates
Last Update Posted (Estimate)
December 2, 2011
Last Update Submitted That Met QC Criteria
December 1, 2011
Last Verified
December 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Endocrine System Diseases
- Digestive System Neoplasms
- Endocrine Gland Neoplasms
- Pancreatic Diseases
- Pancreatic Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Anti-Bacterial Agents
- Antibiotics, Antineoplastic
- Antifungal Agents
- Gemcitabine
- Sirolimus
Other Study ID Numbers
- 07-115
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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