Back to resultsA Randomized Study of Amplimexon (Imexon) With Gemcitabine in Pancreatic Cancer
Primary Purpose
Pancreatic Neoplasms
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
imexon in combination with gemcitabine
imexon placebo + gemcitabine
Sponsored by
About this trial
This is an interventional treatment trial for Pancreatic Neoplasms focused on measuring pancreatic cancer, metastatic, chemotherapy naive
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Birmingham Hematology and Oncology- US Oncology
- AZ Onc Associates D.B.A. Hematology Oncology- US Oncology
- Arizona Clinical Research Center
- Rocky Mountain Cancer Center- US Oncology
- Ocala Oncology Center- US Oncology
- Cancer Centers of Florida- US Oncology
- Peachtree Hematology and Oncology Consultants
- Hematology Oncology Associates of Illinois- US Oncology
- Cancer Care & Hematolog Specialists of Chicagoland- US Oncology
- Central Indiana Cancer Centers- US Oncology
- Northern Indiana Cancer Research Consortium
- Hope Center- US Oncology
- University of Kentucky, Hematology/Oncology/BMT Clinical Research
- Lahey Clinic
- University of Michigan
- University of Minnesota
- Kansas City Cancer Center, LLC- US Oncology
- Comprehensive Cancer Centers of Nevada- US Oncology
- Hunterdon Regional Cancer Center
- Hematology Oncology Associates
- Hematology Oncology Associates
- University of New Mexico
- University of New Mexico Cancer Center South
- New Mexico Cancer Care Associates- US Oncology
- Roswell Park Cancer Institute
- Cancer Center of North Carolina- US Oncology
- Medical Onc Assoc of Wyoming Valley, PC- US Oncology
- Fox Chase Cancer Center
- University of Pittsburgh Cancer Institute
- Pottstown Memorial Medical Center
- Associates in Hematology-Oncology P.C. US Oncology
- Reading Hospital Regional Medical Center
- Sanford Clinic
- Texas Oncology - Amarillo- US Oncology
- Mamie Mcfaddin Ward Cancer Center, Texas Oncology- US Oncology
- Texas Oncology P.A.- Bedford- US Oncology
- Texas Cancer Center at Medical City- US Oncology
- Texas Oncology P.A. - Dallas- US Oncology
- Methodist Charlton Cancer Center - Texas Oncology- US Oncology
- Texas Oncology - Odessa- US Oncology
- Scott and White Hospital and Clinics
- Texas Oncology Cancer Care and Research Center- US Oncology
- Texoma Cancer Center- US Oncology
- Virginia Oncology Associates- US Oncology
- Onc & Hematology Assoc. of Southern VA, Inc D.B.A. - US Oncology
- Swedish Cancer Institute
- Cancer Care Northwest- US Oncology
- Northwest Cancer Specialists- US Oncology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
imexon + gemcitabine
Placebo + gemcitabine
Arm Description
imexon + gemcitabine
Placebo in combination with gemcitabine
Outcomes
Primary Outcome Measures
Overall Survival for the Intent to Treat Population
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
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
Objective Response Rates of the Two Treatment Arms
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.
Progression Free Survival
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00637247
Brief Title
A Randomized Study of Amplimexon (Imexon) With Gemcitabine in Pancreatic Cancer
Official Title
A Phase 2 Randomized, Double-Blind, Multicenter Trial of Amplimexon® Plus Gemcitabine Versus Gemcitabine Plus Placebo in Patients With Metastatic Chemotherapy Naïve Pancreatic Adenocarcinoma (Stage IV)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
April 2008 (Actual)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
June 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AmpliMed Corporation
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Neoplasms
Keywords
pancreatic cancer, metastatic, chemotherapy naive
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
142 (Actual)
8. Arms, Groups, and Interventions
Arm Title
imexon + gemcitabine
Arm Type
Experimental
Arm Description
imexon + gemcitabine
Arm Title
Placebo + gemcitabine
Arm Type
Active Comparator
Arm Description
Placebo in combination with gemcitabine
Intervention Type
Drug
Intervention Name(s)
imexon in combination with gemcitabine
Other Intervention Name(s)
Amplimexon, Gemzar
Intervention Description
875 mg/m^2 imexon IV + 1000 mg/m^2 gemcitabine IV
Intervention Type
Drug
Intervention Name(s)
imexon placebo + gemcitabine
Other Intervention Name(s)
Gemzar
Intervention Description
imexon placebo IV + 1000 mg/m^2 gemcitabine IV
Primary Outcome Measure Information:
Title
Overall Survival for the Intent to Treat Population
Description
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.
Time Frame
up to 2 years
Title
To Evaluate and Compare the Tolerability and Toxicity of the Two Treatment Arms by Comparing Adverse Events
Description
Number of Participants with Adverse Events were compared between the two arms to detect any differences in number or types of events
Time Frame
Adverse events were collected from the time of treatment until the participant went off study treatment, an average of 4 months
Secondary Outcome Measure Information:
Title
Objective Response Rates of the Two Treatment Arms
Description
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.
Time Frame
one year
Title
Progression Free Survival
Description
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.
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Evan Hersh, MD
Organizational Affiliation
AmpliMed Corporation
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Steven Cohen, MD
Organizational Affiliation
Fox Chase Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Birmingham Hematology and Oncology- US Oncology
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
Facility Name
AZ Onc Associates D.B.A. Hematology Oncology- US Oncology
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85704
Country
United States
Facility Name
Arizona Clinical Research Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85715
Country
United States
Facility Name
Rocky Mountain Cancer Center- US Oncology
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
Ocala Oncology Center- US Oncology
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
Facility Name
Cancer Centers of Florida- US Oncology
City
Orlando
State/Province
Florida
ZIP/Postal Code
34761
Country
United States
Facility Name
Peachtree Hematology and Oncology Consultants
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Facility Name
Hematology Oncology Associates of Illinois- US Oncology
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Cancer Care & Hematolog Specialists of Chicagoland- US Oncology
City
Niles
State/Province
Illinois
ZIP/Postal Code
60714
Country
United States
Facility Name
Central Indiana Cancer Centers- US Oncology
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46227
Country
United States
Facility Name
Northern Indiana Cancer Research Consortium
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46601
Country
United States
Facility Name
Hope Center- US Oncology
City
Terre Haute
State/Province
Indiana
ZIP/Postal Code
47802
Country
United States
Facility Name
University of Kentucky, Hematology/Oncology/BMT Clinical Research
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536-0093
Country
United States
Facility Name
Lahey Clinic
City
Burlington
State/Province
Massachusetts
ZIP/Postal Code
01805
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Kansas City Cancer Center, LLC- US Oncology
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64131
Country
United States
Facility Name
Comprehensive Cancer Centers of Nevada- US Oncology
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89169
Country
United States
Facility Name
Hunterdon Regional Cancer Center
City
Flemington
State/Province
New Jersey
ZIP/Postal Code
08822
Country
United States
Facility Name
Hematology Oncology Associates
City
Mount Holly
State/Province
New Jersey
ZIP/Postal Code
08060
Country
United States
Facility Name
Hematology Oncology Associates
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
Facility Name
University of New Mexico
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States
Facility Name
University of New Mexico Cancer Center South
City
Las Cruces
State/Province
New Mexico
ZIP/Postal Code
88011
Country
United States
Facility Name
New Mexico Cancer Care Associates- US Oncology
City
Santa Fe
State/Province
New Mexico
ZIP/Postal Code
87505
Country
United States
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
Facility Name
Cancer Center of North Carolina- US Oncology
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
Medical Onc Assoc of Wyoming Valley, PC- US Oncology
City
Kingston
State/Province
Pennsylvania
ZIP/Postal Code
18704
Country
United States
Facility Name
Fox Chase Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Facility Name
University of Pittsburgh Cancer Institute
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
Pottstown Memorial Medical Center
City
Pottstown
State/Province
Pennsylvania
ZIP/Postal Code
19464
Country
United States
Facility Name
Associates in Hematology-Oncology P.C. US Oncology
City
Upland
State/Province
Pennsylvania
ZIP/Postal Code
19013
Country
United States
Facility Name
Reading Hospital Regional Medical Center
City
West Reading
State/Province
Pennsylvania
ZIP/Postal Code
19611
Country
United States
Facility Name
Sanford Clinic
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57104
Country
United States
Facility Name
Texas Oncology - Amarillo- US Oncology
City
Amarillo
State/Province
Texas
ZIP/Postal Code
79106
Country
United States
Facility Name
Mamie Mcfaddin Ward Cancer Center, Texas Oncology- US Oncology
City
Beaumont
State/Province
Texas
ZIP/Postal Code
77702
Country
United States
Facility Name
Texas Oncology P.A.- Bedford- US Oncology
City
Bedford
State/Province
Texas
ZIP/Postal Code
76022
Country
United States
Facility Name
Texas Cancer Center at Medical City- US Oncology
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Texas Oncology P.A. - Dallas- US Oncology
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Methodist Charlton Cancer Center - Texas Oncology- US Oncology
City
Dallas
State/Province
Texas
ZIP/Postal Code
75237
Country
United States
Facility Name
Texas Oncology - Odessa- US Oncology
City
Odessa
State/Province
Texas
ZIP/Postal Code
79761
Country
United States
Facility Name
Scott and White Hospital and Clinics
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States
Facility Name
Texas Oncology Cancer Care and Research Center- US Oncology
City
Waco
State/Province
Texas
ZIP/Postal Code
76712
Country
United States
Facility Name
Texoma Cancer Center- US Oncology
City
Wichita Falls
State/Province
Texas
ZIP/Postal Code
76310
Country
United States
Facility Name
Virginia Oncology Associates- US Oncology
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Onc & Hematology Assoc. of Southern VA, Inc D.B.A. - US Oncology
City
Salem
State/Province
Virginia
ZIP/Postal Code
24153
Country
United States
Facility Name
Swedish Cancer Institute
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Cancer Care Northwest- US Oncology
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States
Facility Name
Northwest Cancer Specialists- US Oncology
City
Vancouver
State/Province
Washington
ZIP/Postal Code
98684
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
26709865
Citation
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.
Results Reference
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Learn more about this trial
A Randomized Study of Amplimexon (Imexon) With Gemcitabine in Pancreatic Cancer
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