NCT00034502

Brief Summary

This is a non-randomized study in patients who have received prior 5-FU therapy for colorectal cancer. The objective of this trial is to establish a maximum tolerated dose of ALIMTA and irinotecan given in combination as well as to assess the safety and efficacy of this combination for patients with locally advanced or metastatic colorectal cancer. ALIMTA and irinotecan will be given every 21 days.

Trial Health

85
On Track

Trial Health Score

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

Geographic Reach
2 countries

9 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

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

Interventions

Eligibility Criteria

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

You may qualify if:

  • Histologic or cytologic diagnosis of locally or metastatic colorectal cancer
  • Prior therapy with 5-FU for metastatic cancer
  • Adequate bone marrow, liver and kidney function

You may not qualify if:

  • Pregnancy
  • Breast feeding
  • Inability to interrupt aspirin therapy
  • Brain metastasis
  • Patients who have been treated previously with ALIMTA or irinotecan

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

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.

Wichita, Kansas, United States

Location

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.

New York, New York, United States

Location

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.

Pittsburgh, Pennsylvania, United States

Location

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.

Bielefeld, North Rhine-Westphalia, Germany

Location

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.

Halle, Germany

Location

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.

Hamburg, Germany

Location

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.

Homburg/Saar, Germany

Location

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.

Magdeburg, Germany

Location

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.

München, Germany

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

PemetrexedIrinotecan

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

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

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