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

This study has been completed.

Sponsored by:	Eli Lilly and Company
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00034463

Purpose

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	Intervention	Phase
Metastases Cancer	Drug: ALIMTA Drug: folic acid Drug: multi-vitamins	Phase I

MedlinePlus related topics: Cancer

Drug Information available for: Pemetrexed disodium Pemetrexed Folic acid

U.S. FDA Resources

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00034463

Locations

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

Study ID Numbers:	1310, H3E-MC-JMAS
Study First Received:	April 29, 2002
Last Updated:	July 18, 2006
ClinicalTrials.gov Identifier:	NCT00034463
Health Authority:	United States: Food and Drug Administration

Keywords provided by Eli Lilly and Company:

metastatic cancer
chemotherapy

Study placed in the following topic categories:

Pemetrexed
Folic Acid
Neoplasm Metastasis

Additional relevant MeSH terms:

Antimetabolites
Antimetabolites, Antineoplastic
Vitamin B Complex
Molecular Mechanisms of Pharmacological Action
Hematinics
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Hematologic Agents

Enzyme Inhibitors
Folic Acid Antagonists
Pharmacologic Actions
Neoplastic Processes
Neoplasms
Pathologic Processes
Vitamins
Therapeutic Uses
Micronutrients

ClinicalTrials.gov processed this record on January 16, 2009