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

This study has been completed.

First Received on April 29, 2002. Last Updated on July 18, 2006 History of Changes

Sponsor:	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

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

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: Folic acid Pemetrexed Pemetrexed disodium

U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

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

No publications provided

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

Keywords provided by Eli Lilly and Company:

metastatic cancer
chemotherapy

Additional relevant MeSH terms:

Neoplasm Metastasis
Neoplasms
Neoplasms, Second Primary
Neoplastic Processes
Pathologic Processes
Folic Acid
Vitamins
Pemetrexed
Vitamin B Complex
Micronutrients
Growth Substances

Physiological Effects of Drugs
Pharmacologic Actions
Hematinics
Hematologic Agents
Therapeutic Uses
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Antimetabolites, Antineoplastic
Antimetabolites

ClinicalTrials.gov processed this record on February 12, 2012