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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00034463
Recruitment Status : Completed
First Posted : April 30, 2002
Last Update Posted : July 19, 2006
Sponsor:
Information provided by:
Eli Lilly and Company

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Metastases Cancer Drug: ALIMTA Drug: folic acid Drug: multi-vitamins Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: A Phase 1 Trial of ALIMTA (Pemetrexed) in Patients With Locally Advanced or Metastatic Cancer

Resource links provided by the National Library of Medicine


Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00034463


Locations
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United States, Texas
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, United States
Sponsors and Collaborators
Eli Lilly and Company
More Information
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ClinicalTrials.gov Identifier: NCT00034463    
Other Study ID Numbers: 1310
H3E-MC-JMAS
First Posted: April 30, 2002    Key Record Dates
Last Update Posted: July 19, 2006
Last Verified: July 2006
Keywords provided by Eli Lilly and Company:
metastatic cancer
chemotherapy
Additional relevant MeSH terms:
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Neoplasm Metastasis
Neoplastic Processes
Neoplasms
Pathologic Processes
Folic Acid
 Vitamins
Micronutrients
Physiological Effects of Drugs
Hematinics
Vitamin B Complex