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NCT00034463 Clinical Trial

ALIMTA (Pemetrexed) in Patients With Locally Advanced or Metastatic Cancer

Cancer Clinical Trial

Official title:
A Phase 1 Trial of ALIMTA (Pemetrexed) in Patients With Locally Advanced or Metastatic Cancer

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00034463
Other study ID # 1310
Secondary ID H3E-MC-JMAS
Status Completed
Phase Phase 1
First received April 29, 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

This is a non-randomized, phase 1, study with the primary objective of determining the toxicities and establishing the maximum tolerated dose of ALIMTA when administered as a 10 minute infusion every 21 days with folic acid or multi-vitamin supplementation therapy in lightly or heavily pre-treated patients with locally advanced or metastatic cancer.

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:

- Histologic or cytologic diagnosis of metastatic or locally advanced cancer

- Prior chemotherapy is allowed

- Adequate bone marrow, liver and kidney function

Exclusion Criteria:

- Prior treatment with ALIMTA

- Brain metastasis

- Pregnancy or breast feeding

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• ALIMTA

• folic acid

• multi-vitamins

Locations
Country Name City State
United States For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician. San Antonio Texas

Sponsors (1)
Lead Sponsor Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

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