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

Tracking Information
First Received Date ^ICMJE	April 29, 2002
Last Updated Date	July 18, 2006
Start Date ^ICMJE
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00034463 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	ALIMTA (Pemetrexed) in Patients With Locally Advanced or Metastatic Cancer
Official Title ^ICMJE	A Phase 1 Trial of ALIMTA (Pemetrexed) in Patients With Locally Advanced or Metastatic Cancer
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.
Detailed Description
Study Phase	Phase I
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment
Condition ^ICMJE	Metastases Cancer
Intervention ^ICMJE	Drug: ALIMTA Drug: folic acid Drug: multi-vitamins
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00034463
Responsible Party
Study ID Numbers ^ICMJE	1310, H3E-MC-JMAS
Study Sponsor ^ICMJE	Eli Lilly and Company
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Eli Lilly and Company
Verification Date	July 2006
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP