NCT00034463

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 29, 2002

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 30, 2002

Completed
Last Updated

July 19, 2006

Status Verified

July 1, 2006

First QC Date

April 29, 2002

Last Update Submit

July 18, 2006

Conditions

MetastasesCancer

Keywords

metastatic cancerchemotherapy

Interventions

ALIMTADRUG
folic acidDRUG
multi-vitaminsDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologic or cytologic diagnosis of metastatic or locally advanced cancer
  • Prior chemotherapy is allowed
  • Adequate bone marrow, liver and kidney function

You may not qualify if:

  • Prior treatment with ALIMTA
  • Brain metastasis
  • Pregnancy or breast feeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Location

MeSH Terms

Conditions

Neoplasm MetastasisNeoplasms

Interventions

PemetrexedFolic Acid

Condition Hierarchy (Ancestors)

Neoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

GuanineHypoxanthinesPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsGlutamatesAmino Acids, AcidicAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, DicarboxylicPterinsPteridines

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 29, 2002

First Posted

April 30, 2002

Last Updated

July 19, 2006

Record last verified: 2006-07

Locations

US(1)