A Randomized Study of Amplimexon (Imexon) With Gemcitabine in Pancreatic Cancer
- Conditions
- Pancreatic Neoplasms
- Interventions
- Registration Number
- NCT00637247
- Lead Sponsor
- AmpliMed Corporation
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 142
-
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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description imexon + gemcitabine imexon in combination with gemcitabine imexon + gemcitabine Placebo + gemcitabine imexon placebo + gemcitabine Placebo in combination with gemcitabine
- Primary Outcome Measures
Name Time Method Overall Survival for the Intent to Treat Population up to 2 years To compare the overall survival duration of the two treatment arms. Overall survival is measured from the time of randomization until reported death. Subjects were censored at last time known alive if lost to follow-up. Alive patients were censored at the last survival follow-up. Follow-up was monthly after off study treatment.
To Evaluate and Compare the Tolerability and Toxicity of the Two Treatment Arms by Comparing Adverse Events Adverse events were collected from the time of treatment until the participant went off study treatment, an average of 4 months Number of Participants with Adverse Events were compared between the two arms to detect any differences in number or types of events
- Secondary Outcome Measures
Name Time Method Progression Free Survival one year To compare the median progression free survival (PFS) of the two treatment arms. Progression free survival is measured from randomization until the subject has documented disease progression by an objective measure. Subjects were censored if no documented progression had occurred at the one year time point. Subjects must be alive with no more than 20% increase in tumor size to qualify for progression free survival. Changes in tumor size are defined by RECIST criteria.
Objective Response Rates of the Two Treatment Arms one year Objective response is measured by tumor reduction as defined in the RECIST criteria. Tumor shrinkage must be at least 30% to qualify as an objective response.
Trial Locations
- Locations (47)
Cancer Center of North Carolina- US Oncology
🇺🇸Raleigh, North Carolina, United States
Central Indiana Cancer Centers- US Oncology
🇺🇸Indianapolis, Indiana, United States
Northern Indiana Cancer Research Consortium
🇺🇸South Bend, Indiana, United States
Peachtree Hematology and Oncology Consultants
🇺🇸Atlanta, Georgia, United States
Ocala Oncology Center- US Oncology
🇺🇸Ocala, Florida, United States
Cancer Care & Hematolog Specialists of Chicagoland- US Oncology
🇺🇸Niles, Illinois, United States
Comprehensive Cancer Centers of Nevada- US Oncology
🇺🇸Las Vegas, Nevada, United States
Hematology Oncology Associates of Illinois- US Oncology
🇺🇸Chicago, Illinois, United States
Lahey Clinic
🇺🇸Burlington, Massachusetts, United States
University of Kentucky, Hematology/Oncology/BMT Clinical Research
🇺🇸Lexington, Kentucky, United States
Hematology Oncology Associates
🇺🇸Albuquerque, New Mexico, United States
University of New Mexico
🇺🇸Albuquerque, New Mexico, United States
Hope Center- US Oncology
🇺🇸Terre Haute, Indiana, United States
Medical Onc Assoc of Wyoming Valley, PC- US Oncology
🇺🇸Kingston, Pennsylvania, United States
University of Pittsburgh Cancer Institute
🇺🇸Pittsburgh, Pennsylvania, United States
New Mexico Cancer Care Associates- US Oncology
🇺🇸Santa Fe, New Mexico, United States
Pottstown Memorial Medical Center
🇺🇸Pottstown, Pennsylvania, United States
Associates in Hematology-Oncology P.C. US Oncology
🇺🇸Upland, Pennsylvania, United States
Sanford Clinic
🇺🇸Sioux Falls, South Dakota, United States
Mamie Mcfaddin Ward Cancer Center, Texas Oncology- US Oncology
🇺🇸Beaumont, Texas, United States
Texas Oncology P.A. - Dallas- US Oncology
🇺🇸Dallas, Texas, United States
Scott and White Hospital and Clinics
🇺🇸Temple, Texas, United States
Texoma Cancer Center- US Oncology
🇺🇸Wichita Falls, Texas, United States
Northwest Cancer Specialists- US Oncology
🇺🇸Vancouver, Washington, United States
Texas Oncology Cancer Care and Research Center- US Oncology
🇺🇸Waco, 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
Cancer Care Northwest- US Oncology
🇺🇸Spokane, Washington, United States
Methodist Charlton Cancer Center - Texas Oncology- US Oncology
🇺🇸Dallas, Texas, United States
Swedish Cancer Institute
🇺🇸Seattle, Washington, United States
Texas Oncology - Odessa- US Oncology
🇺🇸Odessa, Texas, United States
Texas Cancer Center at Medical City- US Oncology
🇺🇸Dallas, Texas, United States
University of New Mexico Cancer Center South
🇺🇸Las Cruces, New Mexico, United States
Reading Hospital Regional Medical Center
🇺🇸West Reading, Pennsylvania, United States
Birmingham Hematology and Oncology- US Oncology
🇺🇸Birmingham, Alabama, United States
Rocky Mountain Cancer Center- US Oncology
🇺🇸Denver, Colorado, United States
Cancer Centers of Florida- US Oncology
🇺🇸Orlando, Florida, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States
Kansas City Cancer Center, LLC- US Oncology
🇺🇸Kansas City, Missouri, United States
AZ Onc Associates D.B.A. Hematology Oncology- US Oncology
🇺🇸Tucson, Arizona, United States
Arizona Clinical Research Center
🇺🇸Tucson, Arizona, United States
Fox Chase Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
University of Minnesota
🇺🇸Minneapolis, Minnesota, United States
Hunterdon Regional Cancer Center
🇺🇸Flemington, New Jersey, United States
Texas Oncology - Amarillo- US Oncology
🇺🇸Amarillo, Texas, United States
Texas Oncology P.A.- Bedford- US Oncology
🇺🇸Bedford, Texas, United States