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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00035035




Registration number
NCT00035035
Ethics application status
Date submitted
2/05/2002
Date registered
3/05/2002
Date last updated
19/07/2006

Titles & IDs
Public title
A Phase 3 Trial of ALIMTA (LY231514, Pemetrexed) Plus GEMZAR Versus GEMZAR in Patients With Unresectable or Metastatic Cancer of the Pancreas.
Scientific title
A Phase 3 Trial of ALIMTA (LY231514, Pemetrexed) Plus GEMZAR Versus GEMZAR in Patients With Unresectable or Metastatic Cancer of the Pancreas.
Secondary ID [1] 0 0
H3E-MC-JMES
Secondary ID [2] 0 0
5148
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pancreatic Neoplasms 0 0
Metastases, Neoplasm 0 0
Condition category
Condition code
Cancer 0 0 0 0
Pancreatic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - GEMZAR
Treatment: Drugs - ALIMTA

Treatment: Drugs: GEMZAR


Treatment: Drugs: ALIMTA
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
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- Bankstown
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- Kingswood Penrith
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- Wollongong
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- Southport
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- Fitzroy
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- Frankston
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- Bankstown
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- Kingswood Penrith
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- Wollongong
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- Southport
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- Fitzroy
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- Frankston
Recruitment outside Australia
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Eli Lilly and Company
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00035035
Trial related presentations / publications
Public notes

Contacts
Principal investigator
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Contact person for public queries
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Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00035035