AzTrials
AzTrials

Pancreatic NeoplasmsPhase 3NCT00035035

A Phase 3 Trial of ALIMTA (LY231514, Pemetrexed) Plus GEMZAR Versus GEMZAR in Patients With Unresectable or Metastatic Cancer of the Pancreas.

A Phase 3 study testing GEMZAR and ALIMTA in people with Pancreatic Neoplasms and Metastases, Neoplasm, run by Eli Lilly and Company at 114 sites in 18 countries.

Completed

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

Official record
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Trial summary

Definition: This study will compare the drug GEMZAR to a combination of GEMZAR plus ALIMTA for the treatment of cancer of the pancreas. Patients may be able to participate in this study if they have cancer in their pancreas that cannot be removed by surgery OR that has spread to a new site in their body. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pancreatic Neoplasms, Metastases, Neoplasm
What is being tested?
GEMZAR and ALIMTA
How many people
Not given
Where
114 sitesin 18 countries
Study dates
Start not givento not given
Phase
Phase 3
Are there results?
None posted in the registry

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

  • Pancreas cancer that cannot be removed by surgery OR that has spread to a new site in your body.
  • You must have one tumor that can be physically measured or scanned by the doctor.
  • You have not had any chemotherapy, immunotherapy, biologic therapy, or hormonal therapy for pancreas cancer, including 5-FU.
  • You cannot have any radiation for 4 weeks before starting this study, and you cannot have radiation to the whole pelvis.

Who cannot join

  • Treatment with any medication or device that has not been approved by regulatory agencies, like the FDA, at the time you enter the study.
  • Documentation that the cancer has spread to your brain.
  • Pregnant or breastfeeding.
  • A second primary cancer.
  • Unable to stop aspirin or non-steroidal anti-inflammatory agents (like ibuprofen) for 5-8 days.

Trial locations and contacts

114 sites in 18 countries.

114 sites in 18 countries

United States40 sites

  • Study site

    Albuquerque, New Mexico

  • Study site

    Burlington, Massachusetts

  • Study site

    Canton, Ohio

  • Study site

    Charleston, South Carolina

  • Study site

    Chicago, Illinois

  • Study site

    Cleveland, Ohio

  • Study site

    Columbia, South Carolina

  • Study site

    Crestview Hills, Kentucky

  • Study site

    Decatur, Illinois

  • Study site

    Drexel Hill, Pennsylvania

  • Study site

    Fort Collins, Colorado

  • Study site

    Fountain Valley, California

  • Study site

    Fullerton, California

  • Study site

    Hartford, Connecticut

  • Study site

    Harvey, Illinois

  • Study site

    Huntsville, Alabama

  • Study site

    Indianapolis, Indiana

  • Study site

    Johnson City, Tennessee

  • Study site

    Lafayette, Louisiana

  • Study site

    Lake Worth, Florida

  • Study site

    Lancaster, California

  • Study site

    Los Angeles, California

  • Study site

    Louisville, Kentucky

  • Study site

    Marshfield, Wisconsin

  • Study site

    Memphis, Tennessee

  • Study site

    Miami, Florida

  • Study site

    Milwaukee, Wisconsin

  • Study site

    Nashville, Tennessee

  • Study site

    New York, New York

  • Study site

    Omaha, Nebraska

  • Study site

    Pittsburgh, Pennsylvania

  • Study site

    Pomona, California

  • Study site

    San Antonio, Texas

  • Study site

    Santa Rosa, California

  • Study site

    Scarborough, Maine

  • Study site

    Shreveport, Louisiana

  • Study site

    Tacoma, Washington

  • Study site

    Torrance, California

  • Study site

    Tyler, Texas

  • Study site

    Wichita, Kansas

Other trials in United States

Germany11 sites

  • Study site

    Berlin

  • Study site

    Bielefeld, Nordhein-Westfalen

  • Study site

    Bremerhaven

  • Study site

    Frankfurt

  • Study site

    Kaiserslautern

  • Study site

    Karlsruhe

  • Study site

    Magdeburg

  • Study site

    Mannheim

  • Study site

    München

  • Study site

    Neustadt/Suedharz

  • Study site

    Stuttgart

Other trials in Germany

France7 sites

  • Study site

    Lille

  • Study site

    Marseille

  • Study site

    Paris

  • Study site

    Rennes

  • Study site

    Rouen

  • Study site

    Strasbourg, Cedex

  • Study site

    Toulouse

Other trials in France

Australia6 sites

  • Study site

    Bankstown, New South Wales

  • Study site

    Fitzroy, Victoria

  • Study site

    Frankston, Victoria

  • Study site

    Kingswood Penrith, New South Wales

  • Study site

    Southport, Queensland

  • Study site

    Wollongong, New South Wales

Other trials in Australia

United Kingdom6 sites

  • Study site

    Acton, London

  • Study site

    Belfast, Northern Ireland

  • Study site

    Bristol, Avon

  • Study site

    Hull, East Yorkshire

  • Study site

    Manchester

  • Study site

    Northwood, Middlesex

Other trials in United Kingdom

Netherlands5 sites

  • Study site

    Breda

  • Study site

    Enschede

  • Study site

    Roermond

  • Study site

    Sittard

  • Study site

    The Hague

Other trials in Netherlands

Spain5 sites

  • Study site

    Barcelona, Barcelona

  • Study site

    Elche, Alicante

  • Study site

    Madrid, Madrid

  • Study site

    Santa Cruz de Tenerife, Santa Cruz De Tenerife

  • Study site

    Zaragoza, Zaragoza

Other trials in Spain

Sweden5 sites

  • Study site

    Linköping

  • Study site

    Lund

  • Study site

    Malmö

  • Study site

    Stockholm

  • Study site

    Umeå

Other trials in Sweden

Argentina4 sites

  • Study site

    Capitol Federal, Buenos Aires

  • Study site

    Ciudad de Buenos Aires

  • Study site

    Mendoza, Mendoza Province

  • Study site

    Santa Fe, Rosario

Other trials in Argentina

Portugal4 sites

  • Study site

    Lisbon

  • Study site

    Porto

  • Study site

    Santa Maria da Feira

  • Study site

    Santarém

Other trials in Portugal

Taiwan4 sites

  • Study site

    Tainan

  • Study site

    Taipei

  • Study site

    Taoyuan, Kuei-Shan

  • Study site

    Yungkang City, Tainan

Other trials in Taiwan

Austria3 sites

  • Study site

    Innsbruck

  • Study site

    Saint Veit Glan

  • Study site

    Vienna

Other trials in Austria

Belgium3 sites

  • Study site

    Brussels

  • Study site

    Ghent

  • Study site

    Leuven

Other trials in Belgium

Italy3 sites

  • Study site

    Genova

  • Study site

    Ravenna

  • Study site

    Roma

Other trials in Italy

Venezuela3 sites

  • Study site

    Caracas

  • Study site

    Estado Aragua, Maracay

  • Study site

    Valencia, Edo. Aragua

Other trials in Venezuela

Greece2 sites

  • Study site

    Ioannina

  • Study site

    Marousi, Athens

Other trials in Greece

Peru2 sites

  • Study site

    Chiclayo

  • Study site

    Lima

Other trials in Peru

Colombia1 site

  • Study site

    Cali

Other trials in Colombia

About this study

Definition: This study will compare the drug GEMZAR to a combination of GEMZAR plus ALIMTA for the treatment of cancer of the pancreas. Patients may be able to participate in this study if they have cancer in their pancreas that cannot be removed by surgery OR that has spread to a new site in their body.

Being tested
GEMZAR, ALIMTA
Keywords
Pancreas, Cancer, Unresectable or Metastatic Cancer of the Pancreas, Alimta
Medical subject headings
Pancreatic Neoplasms, Neoplasm Metastasis, Neoplasms

What participants receive

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

  • GEMZARDrug

  • ALIMTADrug

Timeline

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

  1. First posted3 May 2002 (estimated)

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00035035
Sponsor's protocol ID
5148
Other IDs
H3E-MC-JMES
Status last verified
Jul 2006
First submitted
2 May 2002
Last updated
19 Jul 2006
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing GEMZAR and ALIMTA in people with Pancreatic Neoplasms and Metastases, Neoplasm, run by Eli Lilly and Company at 114 sites in 18 countries.

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 4 inclusion and 5 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 19 Jul 2006. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 114 sites in United States, Germany, France, Australia, United Kingdom and 13 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00035035.

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 19 Jul 2006.

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