Clinical trial NCT00637247: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pancreatic Neoplasms
Keywords: pancreatic cancer
metastatic
chemotherapy naive
Lead sponsor: AmpliMed Corporation
Sponsor class: INDUSTRY
First posted: 2008-03-17
Enrollment: 142
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. Patients with histologically or cytologically confirmed, chemotherapy naive, metastatic pancreatic adenocarcinoma (Stage IV). This does not include patients with only locally advanced pancreatic cancer.
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:

1. Patients with locally advanced, non-metastatic pancreas cancer (Stage III or below).
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.

Primary outcomes:
measure: Overall Survival for the Intent to Treat Population
timeFrame: up to 2 years
measure: To Evaluate and Compare the Tolerability and Toxicity of the Two Treatment Arms by Comparing Adverse Events
timeFrame: Adverse events were collected from the time of treatment until the participant went off study treatment, an average of 4 months
Secondary outcomes:
measure: Objective Response Rates of the Two Treatment Arms
timeFrame: one year
measure: Progression Free Survival
timeFrame: one year
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Birmingham Hematology and Oncology- US Oncology
state: Alabama
city: Tucson
country: United States
facility: AZ Onc Associates D.B.A. Hematology Oncology- US Oncology
state: Arizona
city: Tucson
country: United States
facility: Arizona Clinical Research Center
state: Arizona
city: Denver
country: United States
facility: Rocky Mountain Cancer Center- US Oncology
state: Colorado
city: Ocala
country: United States
facility: Ocala Oncology Center- US Oncology
state: Florida
city: Orlando
country: United States
facility: Cancer Centers of Florida- US Oncology
state: Florida
city: Atlanta
country: United States
facility: Peachtree Hematology and Oncology Consultants
state: Georgia
city: Chicago
country: United States
facility: Hematology Oncology Associates of Illinois- US Oncology
state: Illinois
city: Niles
country: United States
facility: Cancer Care & Hematolog Specialists of Chicagoland- US Oncology
state: Illinois
city: Indianapolis
country: United States
facility: Central Indiana Cancer Centers- US Oncology
state: Indiana
city: South Bend
country: United States
facility: Northern Indiana Cancer Research Consortium
state: Indiana
city: Terre Haute
country: United States
facility: Hope Center- US Oncology
state: Indiana
city: Lexington
country: United States
facility: University of Kentucky, Hematology/Oncology/BMT Clinical Research
state: Kentucky
city: Burlington
country: United States
facility: Lahey Clinic
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Kansas City
country: United States
facility: Kansas City Cancer Center, LLC- US Oncology
state: Missouri
city: Las Vegas
country: United States
facility: Comprehensive Cancer Centers of Nevada- US Oncology
state: Nevada
city: Flemington
country: United States
facility: Hunterdon Regional Cancer Center
state: New Jersey
city: Mount Holly
country: United States
facility: Hematology Oncology Associates
state: New Jersey
city: Albuquerque
country: United States
facility: Hematology Oncology Associates
state: New Mexico
city: Albuquerque
country: United States
facility: University of New Mexico
state: New Mexico
city: Las Cruces
country: United States
facility: University of New Mexico Cancer Center South
state: New Mexico
city: Santa Fe
country: United States
facility: New Mexico Cancer Care Associates- US Oncology
state: New Mexico
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
city: Raleigh
country: United States
facility: Cancer Center of North Carolina- US Oncology
state: North Carolina
city: Kingston
country: United States
facility: Medical Onc Assoc of Wyoming Valley, PC- US Oncology
state: Pennsylvania
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Cancer Institute
state: Pennsylvania
city: Pottstown
country: United States
facility: Pottstown Memorial Medical Center
state: Pennsylvania
city: Upland
country: United States
facility: Associates in Hematology-Oncology P.C. US Oncology
state: Pennsylvania
city: West Reading
country: United States
facility: Reading Hospital Regional Medical Center
state: Pennsylvania
city: Sioux Falls
country: United States
facility: Sanford Clinic
state: South Dakota
city: Amarillo
country: United States
facility: Texas Oncology - Amarillo- US Oncology
state: Texas
city: Beaumont
country: United States
facility: Mamie Mcfaddin Ward Cancer Center, Texas Oncology- US Oncology
state: Texas
city: Bedford
country: United States
facility: Texas Oncology P.A.- Bedford- US Oncology
state: Texas
city: Dallas
country: United States
facility: Texas Cancer Center at Medical City- US Oncology
state: Texas
city: Dallas
country: United States
facility: Texas Oncology P.A. - Dallas- US Oncology
state: Texas
city: Dallas
country: United States
facility: Methodist Charlton Cancer Center - Texas Oncology- US Oncology
state: Texas
city: Odessa
country: United States
facility: Texas Oncology - Odessa- US Oncology
state: Texas
city: Temple
country: United States
facility: Scott and White Hospital and Clinics
state: Texas
city: Waco
country: United States
facility: Texas Oncology Cancer Care and Research Center- US Oncology
state: Texas
city: Wichita Falls
country: United States
facility: Texoma Cancer Center- US Oncology
state: Texas
city: Norfolk
country: United States
facility: Virginia Oncology Associates- US Oncology
state: Virginia
city: Salem
country: United States
facility: Onc & Hematology Assoc. of Southern VA, Inc D.B.A. - US Oncology
state: Virginia
city: Seattle
country: United States
facility: Swedish Cancer Institute
state: Washington
city: Spokane
country: United States
facility: Cancer Care Northwest- US Oncology
state: Washington
city: Vancouver
country: United States
facility: Northwest Cancer Specialists- US Oncology
state: Washington
Study officials:
affiliation: AmpliMed Corporation
name: Evan Hersh, MD
role: STUDY_DIRECTOR
affiliation: Fox Chase Cancer Center
name: Steven Cohen, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.