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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)


Phase 2
18 Years
N/A
Not Enrolling
Both
Pancreatic Neoplasms

Thank you

Trial Information

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)


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Overall Survival for the Intent to Treat Population

Outcome 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.

Outcome Time Frame:

up to 2 years

Safety Issue:

No

Principal Investigator

Evan Hersh, MD

Investigator Role:

Study Director

Investigator Affiliation:

AmpliMed Corporation

Authority:

United States: Food and Drug Administration

Study ID:

AMP-019

NCT ID:

NCT00637247

Start Date:

April 2008

Completion Date:

June 2010

Related Keywords:

  • Pancreatic Neoplasms
  • pancreatic cancer
  • metastatic
  • chemotherapy naive
  • Neoplasms
  • Pancreatic Neoplasms

Name

Location

University of MichiganAnn Arbor, Michigan  48109-0624
Roswell Park Cancer InstituteBuffalo, New York  14263
Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
University of Pittsburgh Cancer InstitutePittsburgh, Pennsylvania  15213
Swedish Cancer InstituteSeattle, Washington  98104
Hunterdon Regional Cancer CenterFlemington, New Jersey  08822
University of MinnesotaMinneapolis, Minnesota  55455
Arizona Clinical Research CenterTucson, Arizona  85712
Hematology Oncology AssociatesMorristown, New Jersey  07962
Lahey ClinicBurlington, Massachusetts  01805
University of New MexicoAlbuquerque, New Mexico  87131
Northern Indiana Cancer Research ConsortiumSouth Bend, Indiana  
Hematology Oncology AssociatesAlbuquerque, New Mexico  87106
Pottstown Memorial Medical CenterPottstown, Pennsylvania  19464
Peachtree Hematology And Oncology ConsultantsAtlanta, Georgia  30309
Birmingham Hematology and Oncology- US OncologyBirmingham, Alabama  35205
AZ Onc Associates D.B.A. Hematology Oncology- US OncologyTucson, Arizona  85704
Rocky Mountain Cancer Center- US OncologyDenver, Colorado  80218
Ocala Oncology Center- US OncologyOcala, Florida  34471
Cancer Centers of Florida- US OncologyOrlando, Florida  34761
Hematology Oncology Associates of Illinois- US OncologyChicago, Illinois  60611
Cancer Care & Hematolog Specialists of Chicagoland- US OncologyNiles, Illinois  60714
Central Indiana Cancer Centers- US OncologyIndianapolis, Indiana  46227
Hope Center- US OncologyTerre Haute, Indiana  47802
University of Kentucky, Hematology/Oncology/BMT Clinical ResearchLexington, Kentucky  40536-0093
Kansas City Cancer Center, LLC- US OncologyKansas City, Missouri  64131
Comprehensive Cancer Centers of Nevada- US OncologyLas Vegas, Nevada  89169
University of New Mexico Cancer Center SouthLas Cruces, New Mexico  88011
New Mexico Cancer Care Associates- US OncologySanta Fe, New Mexico  87505
Cancer Center of North Carolina- US OncologyRaleigh, North Carolina  27607
Medical Onc Assoc of Wyoming Valley, PC- US OncologyKingston, Pennsylvania  18704
Associates in Hematology-Oncology P.C. US OncologyUpland, Pennsylvania  19013
Reading Hospital Regional Medical CenterWest Reading, Pennsylvania  19611
Sanford ClinicSioux Falls, South Dakota  57104
Texas Oncology - Amarillo- US OncologyAmarillo, Texas  79106
Mamie Mcfaddin Ward Cancer Center, Texas Oncology- US OncologyBeaumont, Texas  77702
Texas Oncology P.A.- Bedford- US OncologyBedford, Texas  76022
Texas Cancer Center at Medical City- US OncologyDallas, Texas  75230
Texas Oncology P.A. - Dallas- US OncologyDallas, Texas  75231
Methodist Charlton Cancer Center - Texas Oncology- US OncologyDallas, Texas  75237
Texas Oncology - Odessa- US OncologyOdessa, Texas  79761
Scott and White Hospital and ClinicsTemple, Texas  76508
Texas Oncology Cancer Care and Research Center- US OncologyWaco, Texas  76712
Texoma Cancer Center- US OncologyWichita Falls, Texas  76310
Virginia Oncology Associates- US OncologyNorfolk, Virginia  23502
Onc & Hematology Assoc. of Southern VA, Inc D.B.A. - US OncologySalem, Virginia  24153
Cancer Care Northwest- US OncologySpokane, Washington  99202
Northwest Cancer Specialists- US OncologyVancouver, Washington  98684