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

NCT00637247 | Completed Phase 2 Results DMC

• 1 other identifier: AMP-019
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 48

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.

Conditions

Pancreatic Neoplasms

Keywords

pancreatic cancer; metastatic; chemotherapy naive

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• Objective Response Rates of the Two Treatment Arms

  one year

• Progression Free Survival

  one year

Study Arms (2)

imexon + gemcitabine

EXPERIMENTAL

imexon + gemcitabine

Drug: imexon in combination with gemcitabine

Placebo + gemcitabine

ACTIVE COMPARATOR

Placebo in combination with gemcitabine

Drug: imexon placebo + gemcitabine

Interventions

imexon in combination with gemcitabine DRUG

875 mg/m\^2 imexon IV + 1000 mg/m\^2 gemcitabine IV

Also known as: Amplimexon, Gemzar

imexon + gemcitabine

imexon placebo + gemcitabine DRUG

imexon placebo IV + 1000 mg/m\^2 gemcitabine IV

Also known as: Gemzar

Placebo + gemcitabine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AmpliMed Corporation: lead

Study Sites (48)

Birmingham Hematology and Oncology- US Oncology

Birmingham, Alabama, 35205, United States

Location

AZ Onc Associates D.B.A. Hematology Oncology- US Oncology

Tucson, Arizona, 85704, United States

Location

Arizona Clinical Research Center

Tucson, Arizona, 85715, United States

Location

Rocky Mountain Cancer Center- US Oncology

Denver, Colorado, 80218, United States

Location

Ocala Oncology Center- US Oncology

Ocala, Florida, 34471, United States

Location

Cancer Centers of Florida- US Oncology

Orlando, Florida, 34761, United States

Location

Peachtree Hematology and Oncology Consultants

Atlanta, Georgia, 30309, United States

Location

Hematology Oncology Associates of Illinois- US Oncology

Chicago, Illinois, 60611, United States

Location

Cancer Care & Hematolog Specialists of Chicagoland- US Oncology

Niles, Illinois, 60714, United States

Location

Central Indiana Cancer Centers- US Oncology

Indianapolis, Indiana, 46227, United States

Location

Northern Indiana Cancer Research Consortium

South Bend, Indiana, 46601, United States

Location

Hope Center- US Oncology

Terre Haute, Indiana, 47802, United States

Location

University of Kentucky, Hematology/Oncology/BMT Clinical Research

Lexington, Kentucky, 40536-0093, United States

Location

Lahey Clinic

Burlington, Massachusetts, 01805, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Kansas City Cancer Center, LLC- US Oncology

Kansas City, Missouri, 64131, United States

Location

Comprehensive Cancer Centers of Nevada- US Oncology

Las Vegas, Nevada, 89169, United States

Location

Hunterdon Regional Cancer Center

Flemington, New Jersey, 08822, United States

Location

Hematology Oncology Associates

Mount Holly, New Jersey, 08060, United States

Location

Hematology Oncology Associates

Albuquerque, New Mexico, 87106, United States

Location

University of New Mexico

Albuquerque, New Mexico, 87131, United States

Location

University of New Mexico Cancer Center South

Las Cruces, New Mexico, 88011, United States

Location

New Mexico Cancer Care Associates- US Oncology

Santa Fe, New Mexico, 87505, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

Cancer Center of North Carolina- US Oncology

Raleigh, North Carolina, 27607, United States

Location

Medical Onc Assoc of Wyoming Valley, PC- US Oncology

Kingston, Pennsylvania, 18704, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

University of Pittsburgh Cancer Institute

Pittsburgh, Pennsylvania, 15232, United States

Location

Pottstown Memorial Medical Center

Pottstown, Pennsylvania, 19464, United States

Location

Associates in Hematology-Oncology P.C. US Oncology

Upland, Pennsylvania, 19013, United States

Location

Reading Hospital Regional Medical Center

West Reading, Pennsylvania, 19611, United States

Location

Sanford Clinic

Sioux Falls, South Dakota, 57104, United States

Location

Texas Oncology - Amarillo- US Oncology

Amarillo, Texas, 79106, United States

Location

Mamie Mcfaddin Ward Cancer Center, Texas Oncology- US Oncology

Beaumont, Texas, 77702, United States

Location

Texas Oncology P.A.- Bedford- US Oncology

Bedford, Texas, 76022, United States

Location

Texas Cancer Center at Medical City- US Oncology

Dallas, Texas, 75230, United States

Location

Texas Oncology P.A. - Dallas- US Oncology

Dallas, Texas, 75231, United States

Location

Methodist Charlton Cancer Center - Texas Oncology- US Oncology

Dallas, Texas, 75237, United States

Location

Texas Oncology - Odessa- US Oncology

Odessa, Texas, 79761, United States

Location

Scott and White Hospital and Clinics

Temple, Texas, 76508, United States

Location

Texas Oncology Cancer Care and Research Center- US Oncology

Waco, Texas, 76712, United States

Location

Texoma Cancer Center- US Oncology

Wichita Falls, Texas, 76310, United States

Location

Virginia Oncology Associates- US Oncology

Norfolk, Virginia, 23502, United States

Location

Onc & Hematology Assoc. of Southern VA, Inc D.B.A. - US Oncology

Salem, Virginia, 24153, United States

Location

Swedish Cancer Institute

Seattle, Washington, 98104, United States

Location

Cancer Care Northwest- US Oncology

Spokane, Washington, 99202, United States

Location

Northwest Cancer Specialists- US Oncology

Vancouver, Washington, 98684, United States

Location

Related Publications (1)

• 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.

  PMID: 26709865 BACKGROUND

MeSH Terms

Conditions

Pancreatic Neoplasms; Neoplasm Metastasis

Interventions

4-imino-1,3-diazabicyclo(3.1.0)hexan-2-one; Gemcitabine

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Robert Dorr
• Organization: AmpliMed Corporation

bdorr@azcc.arizona.edu

520-626-7892

Study Officials

• Evan Hersh, MD

  AmpliMed Corporation

  STUDY DIRECTOR

• Steven Cohen, MD

  Fox Chase Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2008
• First Posted: March 17, 2008
• Study Start: April 1, 2008
• Primary Completion: May 1, 2010
• Study Completion: June 1, 2010
• Last Updated: March 20, 2019
• Results First Posted: November 30, 2010

Record last verified: 2019-03

Locations

US (48)