A Randomized Study of Amplimexon (Imexon) With Gemcitabine in Pancreatic Cancer
NCT ID: NCT00637247
Last Updated: 2019-03-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
142 participants
INTERVENTIONAL
2008-04-30
2010-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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imexon + gemcitabine
imexon + gemcitabine
imexon in combination with gemcitabine
875 mg/m\^2 imexon IV + 1000 mg/m\^2 gemcitabine IV
Placebo + gemcitabine
Placebo in combination with gemcitabine
imexon placebo + gemcitabine
imexon placebo IV + 1000 mg/m\^2 gemcitabine IV
Interventions
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imexon in combination with gemcitabine
875 mg/m\^2 imexon IV + 1000 mg/m\^2 gemcitabine IV
imexon placebo + gemcitabine
imexon placebo IV + 1000 mg/m\^2 gemcitabine IV
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. At least one unidimensional measurable metastatic lesion by contrast enhanced CT scan (or MRI in patients ineligible for contrast enhanced CT) that are outside any prior radiation port.
3. Age at least 18 years.
4. ECOG performance status 0 or 1.
5. No prior chemotherapy or radiation therapy.
6. Projected life expectancy at least 2 months.
7. If female, neither pregnant nor lactating.
8. If of child bearing potential must agree to, and be able to use adequate contraception.
9. Concomitant disease: No respiratory insufficiency requiring oxygen therapy; no angina at rest; no myocardial infarction in previous 3 months; no life threatening ventricular arrhythmias. No uncompensated CHF or NY Heart Association class 3 or 4 cardiac disease.
10. No other concurrent active malignancy.
11. No infection requiring parenteral antibiotic therapy at the start of protocol treatment.
12. Laboratory values within the following criteria:
Hgb greater than or equal to 9 gm/dL WBC greater than or equal 3,500/mm\^3 ANC greater than or equal 1,500/mm\^3 Platelet count greater than or equal 100,000/mm\^3 Creatinine greater than or equal 2.0 Bilirubin less than or equal to 2.0 Hepatic enzymes (AST, ALT) less than or equal 3 times upper limit of normal (ULN)
13. G6PD level greater than or equal lower limit of normal (LLN).
14. Able to render informed consent and follow protocol requirements.
Exclusion Criteria
2. Age less than 18 years.
3. ECOG performance status 2 or greater.
4. Prior anticancer drug therapy for metastatic disease.
5. Ascites.
6. Prior abdominal or thoracic surgery \< 4 weeks before the start of therapy.
7. Current or prior brain metastases. Brain MRI or CT required pre-registration only if the patient has CNS symptoms indicating a need for evaluation.
8. Life expectancy projected less than 2 months.
9. Pregnancy or lactation.
10. Unable or unwilling to utilize medically acceptable contraception if of childbearing potential.
11. Laboratory parameters outside of specified ranges, (see above).
12. Infection requiring parenteral antibiotics.
13. NY Heart Association stage 3 or 4 heart disease.
14. Unable to render informed consent.
15. Failure to meet any of the eligibility criteria as outlined above.
18 Years
ALL
No
Sponsors
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AmpliMed Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Evan Hersh, MD
Role: STUDY_DIRECTOR
AmpliMed Corporation
Steven Cohen, MD
Role: PRINCIPAL_INVESTIGATOR
Fox Chase Cancer Center
Locations
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Birmingham Hematology and Oncology- US Oncology
Birmingham, Alabama, United States
AZ Onc Associates D.B.A. Hematology Oncology- US Oncology
Tucson, Arizona, United States
Arizona Clinical Research Center
Tucson, Arizona, United States
Rocky Mountain Cancer Center- US Oncology
Denver, Colorado, United States
Ocala Oncology Center- US Oncology
Ocala, Florida, United States
Cancer Centers of Florida- US Oncology
Orlando, Florida, United States
Peachtree Hematology and Oncology Consultants
Atlanta, Georgia, United States
Hematology Oncology Associates of Illinois- US Oncology
Chicago, Illinois, United States
Cancer Care & Hematolog Specialists of Chicagoland- US Oncology
Niles, Illinois, United States
Central Indiana Cancer Centers- US Oncology
Indianapolis, Indiana, United States
Northern Indiana Cancer Research Consortium
South Bend, Indiana, United States
Hope Center- US Oncology
Terre Haute, Indiana, United States
University of Kentucky, Hematology/Oncology/BMT Clinical Research
Lexington, Kentucky, United States
Lahey Clinic
Burlington, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
University of Minnesota
Minneapolis, Minnesota, United States
Kansas City Cancer Center, LLC- US Oncology
Kansas City, Missouri, United States
Comprehensive Cancer Centers of Nevada- US Oncology
Las Vegas, Nevada, United States
Hunterdon Regional Cancer Center
Flemington, New Jersey, United States
Hematology Oncology Associates
Mount Holly, New Jersey, United States
Hematology Oncology Associates
Albuquerque, New Mexico, United States
University of New Mexico
Albuquerque, New Mexico, United States
University of New Mexico Cancer Center South
Las Cruces, New Mexico, United States
New Mexico Cancer Care Associates- US Oncology
Santa Fe, New Mexico, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Cancer Center of North Carolina- US Oncology
Raleigh, North Carolina, United States
Medical Onc Assoc of Wyoming Valley, PC- US Oncology
Kingston, Pennsylvania, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States
Pottstown Memorial Medical Center
Pottstown, Pennsylvania, United States
Associates in Hematology-Oncology P.C. US Oncology
Upland, Pennsylvania, United States
Reading Hospital Regional Medical Center
West Reading, Pennsylvania, United States
Sanford Clinic
Sioux Falls, South Dakota, United States
Texas Oncology - Amarillo- US Oncology
Amarillo, Texas, United States
Mamie Mcfaddin Ward Cancer Center, Texas Oncology- US Oncology
Beaumont, Texas, United States
Texas Oncology P.A.- Bedford- US Oncology
Bedford, Texas, United States
Texas Cancer Center at Medical City- US Oncology
Dallas, Texas, United States
Texas Oncology P.A. - Dallas- US Oncology
Dallas, Texas, United States
Methodist Charlton Cancer Center - Texas Oncology- US Oncology
Dallas, Texas, United States
Texas Oncology - Odessa- US Oncology
Odessa, Texas, United States
Scott and White Hospital and Clinics
Temple, Texas, United States
Texas Oncology Cancer Care and Research Center- US Oncology
Waco, Texas, United States
Texoma Cancer Center- US Oncology
Wichita Falls, Texas, United States
Virginia Oncology Associates- US Oncology
Norfolk, Virginia, United States
Onc & Hematology Assoc. of Southern VA, Inc D.B.A. - US Oncology
Salem, Virginia, United States
Swedish Cancer Institute
Seattle, Washington, United States
Cancer Care Northwest- US Oncology
Spokane, Washington, United States
Northwest Cancer Specialists- US Oncology
Vancouver, Washington, United States
Countries
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References
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Cohen SJ, Zalupski MM, Conkling P, Nugent F, Ma WW, Modiano M, Pascual R, Lee FC, Wong L, Hersh E. A Phase 2 Randomized, Double-Blind, Multicenter Trial of Imexon Plus Gemcitabine Versus Gemcitabine Plus Placebo in Patients With Metastatic Chemotherapy-naive Pancreatic Adenocarcinoma. Am J Clin Oncol. 2018 Mar;41(3):230-235. doi: 10.1097/COC.0000000000000260.
Other Identifiers
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AMP-019
Identifier Type: -
Identifier Source: org_study_id
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