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

Pancreatic Neoplasms Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00637247
• Other study ID #: AMP-019
• Status: Completed
• Phase: Phase 2
• Start date: April 2008
• Est. completion date: June 2010

Study information

• Verified date: March 2019
• Source: AmpliMed Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 142
• Est. completion date: June 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pancreatic Neoplasms

Intervention

Drug:
• 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

Locations

Country	Name	City	State
United States	Hematology Oncology Associates	Albuquerque	New Mexico
United States	University of New Mexico	Albuquerque	New Mexico
United States	Texas Oncology - Amarillo- US Oncology	Amarillo	Texas
United States	University of Michigan	Ann Arbor	Michigan
United States	Peachtree Hematology and Oncology Consultants	Atlanta	Georgia
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	Birmingham Hematology and Oncology- US Oncology	Birmingham	Alabama
United States	Roswell Park Cancer Institute	Buffalo	New York
United States	Lahey Clinic	Burlington	Massachusetts
United States	Hematology Oncology Associates of Illinois- US Oncology	Chicago	Illinois
United States	Methodist Charlton Cancer Center - Texas Oncology- US Oncology	Dallas	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	Rocky Mountain Cancer Center- US Oncology	Denver	Colorado
United States	Hunterdon Regional Cancer Center	Flemington	New Jersey
United States	Central Indiana Cancer Centers- US Oncology	Indianapolis	Indiana
United States	Kansas City Cancer Center, LLC- US Oncology	Kansas City	Missouri
United States	Medical Onc Assoc of Wyoming Valley, PC- US Oncology	Kingston	Pennsylvania
United States	University of New Mexico Cancer Center South	Las Cruces	New Mexico
United States	Comprehensive Cancer Centers of Nevada- US Oncology	Las Vegas	Nevada
United States	University of Kentucky, Hematology/Oncology/BMT Clinical Research	Lexington	Kentucky
United States	University of Minnesota	Minneapolis	Minnesota
United States	Hematology Oncology Associates	Mount Holly	New Jersey
United States	Cancer Care & Hematolog Specialists of Chicagoland- US Oncology	Niles	Illinois
United States	Virginia Oncology Associates- US Oncology	Norfolk	Virginia
United States	Ocala Oncology Center- US Oncology	Ocala	Florida
United States	Texas Oncology - Odessa- US Oncology	Odessa	Texas
United States	Cancer Centers of Florida- US Oncology	Orlando	Florida
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	Cancer Center of North Carolina- US Oncology	Raleigh	North Carolina
United States	Onc & Hematology Assoc. of Southern VA, Inc D.B.A. - US Oncology	Salem	Virginia
United States	New Mexico Cancer Care Associates- US Oncology	Santa Fe	New Mexico
United States	Swedish Cancer Institute	Seattle	Washington
United States	Sanford Clinic	Sioux Falls	South Dakota
United States	Northern Indiana Cancer Research Consortium	South Bend	Indiana
United States	Cancer Care Northwest- US Oncology	Spokane	Washington
United States	Scott and White Hospital and Clinics	Temple	Texas
United States	Hope Center- US Oncology	Terre Haute	Indiana
United States	Arizona Clinical Research Center	Tucson	Arizona
United States	AZ Onc Associates D.B.A. Hematology Oncology- US Oncology	Tucson	Arizona
United States	Associates in Hematology-Oncology P.C. US Oncology	Upland	Pennsylvania
United States	Northwest Cancer Specialists- US Oncology	Vancouver	Washington
United States	Texas Oncology Cancer Care and Research Center- US Oncology	Waco	Texas
United States	Reading Hospital Regional Medical Center	West Reading	Pennsylvania
United States	Texoma Cancer Center- US Oncology	Wichita Falls	Texas

Sponsors (1)

Lead Sponsor	Collaborator
AmpliMed Corporation

Country where clinical trial is conducted

United States, 

References & Publications (1)

S. J. Cohen, M. M. Zalupski, P. Conkling, F. W. Nugent, W. Ma, M. Modiano, R. A. Pascual, F. Lee, L. Wong, E. Hersh, J Clin Oncol 28:15s, 2010 (suppl; abstr 4076)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	up to 2 years
Primary	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	Adverse events were collected from the time of treatment until the participant went off study treatment, an average of 4 months
Secondary	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.	one year
Secondary	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.	one year