A Randomized Study of Amplimexon (Imexon) With Gemcitabine in Pancreatic Cancer

Completed · Phase 2 · Has a placebo group

Conditions studied: Pancreatic Neoplasms

In brief

The purpose of this study is to determine if imexon in combination with gemcitabine could improve overall survival as compared to gemcitabine alone in subjects with pancreatic cancer that has spread to other organs such as the liver or lungs. The study will also look at the safety of the combination as compared to gemcitabine alone. Participants in the study will be randomly assigned to either treatment and neither the participant or their doctors will know which treatment they will be receiving.

Key facts

Study ID

NCT00637247

Run by

AmpliMed Corporation

People needed

142

Starts

2008-04-01

Expected to finish

2010-06-01

Last updated by the study team

2019-03-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with histologically or cytologically confirmed, chemotherapy naive, metastatic pancreatic adenocarcinoma (Stage IV). This does not include patients with only locally advanced pancreatic cancer.
• 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.
• Age at least 18 years.
• ECOG performance status 0 or 1.
• No prior chemotherapy or radiation therapy.
• Projected life expectancy at least 2 months.
• If female, neither pregnant nor lactating.
• If of child bearing potential must agree to, and be able to use adequate contraception.
• 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.
• No other concurrent active malignancy.
• No infection requiring parenteral antibiotic therapy at the start of protocol treatment.
• 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)
• G6PD level greater than or equal lower limit of normal (LLN).
• Able to render informed consent and follow protocol requirements.

You may not qualify if…

• Patients with locally advanced, non-metastatic pancreas cancer (Stage III or below).
• Age less than 18 years.
• ECOG performance status 2 or greater.
• Prior anticancer drug therapy for metastatic disease.
• Ascites.
• Prior abdominal or thoracic surgery < 4 weeks before the start of therapy.
• Current or prior brain metastases. Brain MRI or CT required pre-registration only if the patient has CNS symptoms indicating a need for evaluation.
• Life expectancy projected less than 2 months.
• Pregnancy or lactation.
• Unable or unwilling to utilize medically acceptable contraception if of childbearing potential.
• Laboratory parameters outside of specified ranges, (see above).
• Infection requiring parenteral antibiotics.
• NY Heart Association stage 3 or 4 heart disease.
• Unable to render informed consent.
• Failure to meet any of the eligibility criteria as outlined above.

Where it is running

• 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

Full record on ClinicalTrials.gov

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