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NCT00035035 Clinical Trial

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

Pancreatic Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00035035
Other study ID # 5148
Secondary ID H3E-MC-JMES
Status Completed
Phase Phase 3
First received May 2, 2002
Last updated July 18, 2006

Study information
Verified date July 2006
Source Eli Lilly and Company
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical 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.

Other known NCT identifiers
  • NCT00049426

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• GEMZAR

• ALIMTA

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

United States,  Venezuela,  Argentina,  Australia,  Austria,  Belgium,  Colombia,  France,  Germany,  Greece,  Italy,  Netherlands,  Peru,  Portugal,  Spain,  Sweden,  Taiwan,  United Kingdom, 

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