Clinical trial NCT00035035: A Phase 3 Trial of ALIMTA (LY231514, Pemetrexed) Plus GEMZAR Versus GEMZAR in Patients With Unresectable or Metastatic Cancer of the Pancreas.
Official title: A Phase 3 Trial of ALIMTA (LY231514, Pemetrexed) Plus GEMZAR Versus GEMZAR in Patients With Unresectable or Metastatic Cancer of the Pancreas.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pancreatic Neoplasms
Metastases, Neoplasm
Keywords: Pancreas
Cancer
Unresectable or Metastatic Cancer of the Pancreas
Alimta
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2002-05-03
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Huntsville
country: United States
state: Alabama
city: Fountain Valley
country: United States
state: California
city: Fullerton
country: United States
state: California
city: Lancaster
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Pomona
country: United States
state: California
city: Santa Rosa
country: United States
state: California
city: Torrance
country: United States
state: California
city: Fort Collins
country: United States
state: Colorado
city: Hartford
country: United States
state: Connecticut
city: Lake Worth
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Chicago
country: United States
state: Illinois
city: Decatur
country: United States
state: Illinois
city: Harvey
country: United States
state: Illinois
city: Indianapolis
country: United States
state: Indiana
city: Wichita
country: United States
state: Kansas
city: Crestview Hills
country: United States
state: Kentucky
city: Louisville
country: United States
state: Kentucky
city: Lafayette
country: United States
state: Louisiana
city: Shreveport
country: United States
state: Louisiana
city: Scarborough
country: United States
state: Maine
city: Burlington
country: United States
state: Massachusetts
city: Omaha
country: United States
state: Nebraska
city: Albuquerque
country: United States
state: New Mexico
city: New York
country: United States
state: New York
city: Canton
country: United States
state: Ohio
city: Cleveland
country: United States
state: Ohio
city: Drexel Hill
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Charleston
country: United States
state: South Carolina
city: Columbia
country: United States
state: South Carolina
city: Johnson City
country: United States
state: Tennessee
city: Memphis
country: United States
state: Tennessee
city: Nashville
country: United States
state: Tennessee
city: San Antonio
country: United States
state: Texas
city: Tyler
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state: Texas
city: Tacoma
country: United States
state: Washington
city: Marshfield
country: United States
state: Wisconsin
city: Milwaukee
country: United States
state: Wisconsin
city: Capitol Federal
country: Argentina
state: Buenos Aires
city: Santa Fe
country: Argentina
state: Rosario
city: Ciudad De Buenos Aires
country: Argentina
city: Mendoza
country: Argentina
city: Bankstown
country: Australia
state: New South Wales
city: Kingswood Penrith
country: Australia
state: New South Wales
city: Wollongong
country: Australia
state: New South Wales
city: Southport
country: Australia
state: Queensland
city: Fitzroy
country: Australia
state: Victoria
city: Frankston
country: Australia
state: Victoria
city: Innsbruck
country: Austria
city: St. Veit Glan
country: Austria
city: Wien
country: Austria
city: Brussels
country: Belgium
city: Gent
country: Belgium
city: Leuven
country: Belgium
city: Cali
country: Colombia
city: Strasbourg
country: France
state: Cedex
city: Lille Cedex
country: France
city: Marseille
country: France
city: Paris Cedex 10
country: France
city: Paris Cedex 13
country: France
city: Rennes Cedex
country: France
city: Rouen Cedex
country: France
city: Toulouse Cedex
country: France
city: Bielefeld
country: Germany
state: Nordhein-Westfalen
city: Berlin
country: Germany
city: Bremerhaven
country: Germany
city: Frankfurt
country: Germany
city: Kaiserslautern
country: Germany
city: Karlsruhe
country: Germany
city: Magdeburg
country: Germany
city: Mannheim
country: Germany
city: Munchen
country: Germany
city: Neustadt/Suedharz
country: Germany
city: Stuttgart
country: Germany
city: Maroussi
country: Greece
state: Athens
city: Ioannina
country: Greece
city: Genova
country: Italy
city: Ravenna
country: Italy
city: Roma
country: Italy
city: Breda
country: Netherlands
city: Den Haag
country: Netherlands
city: Enschede
country: Netherlands
city: Roermond
country: Netherlands
city: Sittard
country: Netherlands
city: Chiclayo
country: Peru
city: Lima
country: Peru
city: Lisboa
country: Portugal
city: Porto
country: Portugal
city: Santa Maria Da Feira
country: Portugal
city: Santarem
country: Portugal
city: Elche
country: Spain
state: Alicante
city: Barcelona
country: Spain
city: Madrid
country: Spain
city: Santa Cruz De Tenerife
country: Spain
city: Zaragoza
country: Spain
city: Linkoping
country: Sweden
city: Lund
country: Sweden
city: Malmo
country: Sweden
city: Stockholm
country: Sweden
city: Umea
country: Sweden
city: Tao-Yuan
country: Taiwan
state: Kuei-Shan
city: Yungkang City
country: Taiwan
state: Tainan
city: Tainan
country: Taiwan
city: Taipei
country: Taiwan
city: Bristol
country: United Kingdom
state: Avon
city: Hull
country: United Kingdom
state: East Yorkshire
city: Acton
country: United Kingdom
state: London
city: Northwood
country: United Kingdom
state: Middlesex
city: Belfast
country: United Kingdom
state: Northern Ireland
city: Manchester
country: United Kingdom
city: Valencia
country: Venezuela
state: Edo. Aragua
city: Estado Aragua
country: Venezuela
state: Maracay
city: Caracas
country: Venezuela
Study officials:
References: