Safety Study of Imexon Plus Gemcitabine in Untreated Pancreatic Adenocarcinoma
NCT ID: NCT00327327
Last Updated: 2010-09-15
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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COMPLETED
PHASE1
105 participants
INTERVENTIONAL
2004-02-29
2009-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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imexon
30-60 minutes IV, days 1,8,15 every 28 days
gemcitabine
30 minutes IV, days 1,8,15 every 28 days
Eligibility Criteria
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Inclusion Criteria
* Blood cell counts and blood chemistries in or near normal range.
* Able to perform the activities of daily living.
* A projected life expectancy of at least 2 months.
* If female, neither pregnant nor nursing.
* Willing to use contraceptives to prevent pregnancy.
* No other serious illnesses.
* No other active malignancy.
* No serious infections.
* No current other drug therapy for the cancer or steroid therapy.
* Prior radiation is permitted as is chemotherapy given during radiation or to prevent relapse after surgical removal of the disease.
Exclusion Criteria
* Brain metastases
18 Years
ALL
No
Sponsors
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AmpliMed Corporation
INDUSTRY
Responsible Party
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AmpliMed Corporation
Principal Investigators
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Mark Zalupski, MD
Role: PRINCIPAL_INVESTIGATOR
University of Michigan
Steven Cohen, MD
Role: PRINCIPAL_INVESTIGATOR
Fox Chase Cancer Center
Locations
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Arizona Clinical Research Center
Tucson, Arizona, United States
US Oncology Orlando, Cancer Centers of FL
Ocoee, Florida, United States
US Oncology Indiana
Indianapolis, Indiana, United States
Univ of Michigan
Ann Arbor, Michigan, United States
US Oncology Albany, New York Oncology
Albany, New York, United States
US Oncology Kettering
Kettering, Ohio, United States
Fox Chase Cancer Ctr.
Philadelphia, Pennsylvania, United States
US Oncology, Virginia Oncology Assoc
Norfolk, Virginia, United States
US Oncology Northwest, Northwest Cancer Specialists
Vancouver, Washington, United States
Countries
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References
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Cohen SJ, Zalupski MM, Modiano MR, Conkling P, Patt YZ, Davis P, Dorr RT, Boytim ML, Hersh EM. A phase I study of imexon plus gemcitabine as first-line therapy for advanced pancreatic cancer. Cancer Chemother Pharmacol. 2010 Jul;66(2):287-94. doi: 10.1007/s00280-009-1162-y. Epub 2009 Oct 24.
Other Identifiers
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AMP-004
Identifier Type: -
Identifier Source: org_study_id