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Pancreatic NeoplasmsPhase 2NCT00637247

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

A Phase 2 study testing imexon in combination with gemcitabine in people with Pancreatic Neoplasms, run by AmpliMed Corporation at 48 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pancreatic Neoplasms
What is being tested?
imexon in combination with gemcitabine
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
142 participants
Where
48 sitesUnited States
Study dates
Apr 2008to Jun 2010
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

48 sites in 1 country.

48 sites in 1 country

United States48 sites

  • Hematology Oncology Associates

    Albuquerque, New Mexico, 87106

  • University of New Mexico

    Albuquerque, New Mexico, 87131

  • Texas Oncology - Amarillo- US Oncology

    Amarillo, Texas, 79106

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • Peachtree Hematology and Oncology Consultants

    Atlanta, Georgia, 30309

  • Mamie Mcfaddin Ward Cancer Center, Texas Oncology- US Oncology

    Beaumont, Texas, 77702

  • Texas Oncology P.A.- Bedford- US Oncology

    Bedford, Texas, 76022

  • Birmingham Hematology and Oncology- US Oncology

    Birmingham, Alabama, 35205

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

  • Lahey Clinic

    Burlington, Massachusetts, 01805

  • Hematology Oncology Associates of Illinois- US Oncology

    Chicago, Illinois, 60611

  • Texas Cancer Center at Medical City- US Oncology

    Dallas, Texas, 75230

  • Texas Oncology P.A. - Dallas- US Oncology

    Dallas, Texas, 75231

  • Methodist Charlton Cancer Center - Texas Oncology- US Oncology

    Dallas, Texas, 75237

  • Rocky Mountain Cancer Center- US Oncology

    Denver, Colorado, 80218

  • Hunterdon Regional Cancer Center

    Flemington, New Jersey, 08822

  • Central Indiana Cancer Centers- US Oncology

    Indianapolis, Indiana, 46227

  • Kansas City Cancer Center, LLC- US Oncology

    Kansas City, Missouri, 64131

  • Medical Onc Assoc of Wyoming Valley, PC- US Oncology

    Kingston, Pennsylvania, 18704

  • University of New Mexico Cancer Center South

    Las Cruces, New Mexico, 88011

  • Comprehensive Cancer Centers of Nevada- US Oncology

    Las Vegas, Nevada, 89169

  • University of Kentucky, Hematology/Oncology/BMT Clinical Research

    Lexington, Kentucky, 40536-0093

  • University of Minnesota

    Minneapolis, Minnesota, 55455

  • Hematology Oncology Associates

    Mount Holly, New Jersey, 08060

  • Cancer Care & Hematolog Specialists of Chicagoland- US Oncology

    Niles, Illinois, 60714

  • Virginia Oncology Associates- US Oncology

    Norfolk, Virginia, 23502

  • Ocala Oncology Center- US Oncology

    Ocala, Florida, 34471

  • Texas Oncology - Odessa- US Oncology

    Odessa, Texas, 79761

  • Cancer Centers of Florida- US Oncology

    Orlando, Florida, 34761

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

  • University of Pittsburgh Cancer Institute

    Pittsburgh, Pennsylvania, 15232

  • Pottstown Memorial Medical Center

    Pottstown, Pennsylvania, 19464

  • Cancer Center of North Carolina- US Oncology

    Raleigh, North Carolina, 27607

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

    Salem, Virginia, 24153

  • New Mexico Cancer Care Associates- US Oncology

    Santa Fe, New Mexico, 87505

  • Swedish Cancer Institute

    Seattle, Washington, 98104

  • Sanford Clinic

    Sioux Falls, South Dakota, 57104

  • Northern Indiana Cancer Research Consortium

    South Bend, Indiana, 46601

  • Cancer Care Northwest- US Oncology

    Spokane, Washington, 99202

  • Scott and White Hospital and Clinics

    Temple, Texas, 76508

  • Hope Center- US Oncology

    Terre Haute, Indiana, 47802

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

    Tucson, Arizona, 85704

  • Arizona Clinical Research Center

    Tucson, Arizona, 85715

  • Associates in Hematology-Oncology P.C. US Oncology

    Upland, Pennsylvania, 19013

  • Northwest Cancer Specialists- US Oncology

    Vancouver, Washington, 98684

  • Texas Oncology Cancer Care and Research Center- US Oncology

    Waco, Texas, 76712

  • Reading Hospital Regional Medical Center

    West Reading, Pennsylvania, 19611

  • Texoma Cancer Center- US Oncology

    Wichita Falls, Texas, 76310

Other trials in United States

About this study

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)

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.

Being tested
imexon in combination with gemcitabine, imexon placebo + gemcitabine
Keywords
pancreatic cancer, metastatic, chemotherapy naive
Medical subject headings
Pancreatic Neoplasms, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • imexon in combination with gemcitabineDrug

    Also called Amplimexon, Gemzar

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

  • imexon placebo + gemcitabineDrug

    Also called Gemzar

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

Study groups in NCT00637247
Study groupRoleWhat they receive
imexon + gemcitabineExperimentalimexon + gemcitabine
Receives: Drug: imexon in combination with gemcitabine
Placebo + gemcitabineActive comparatorPlacebo in combination with gemcitabine
Receives: Drug: imexon placebo + gemcitabine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: up to 2 years

  2. 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

    Measured: Adverse events were collected from the time of treatment until the participant went off study treatment, an average of 4 months

Secondary outcomes (2)

  1. 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.

    Measured: one year

  2. 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.

    Measured: one year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Mar 2008 (estimated)
  2. Study startApr 2008
  3. Primary completionMay 2010
  4. Study completionJun 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
142 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00637247
Sponsor's protocol ID
AMP-019
Status last verified
Mar 2019
First submitted
10 Mar 2008
Last updated
20 Mar 2019
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 26709865

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing imexon in combination with gemcitabine in people with Pancreatic Neoplasms, run by AmpliMed Corporation at 48 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 48 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Nov 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival for the Intent to Treat Population (time frame: up to 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00637247, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2019.

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