A Trial of ALIMTA (Pemetrexed) Plus Irinotecan in Patients Who Have Been Previously Treated For Metastatic Colorectal Cancer.

Colorectal Cancer Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00034502
• Other study ID #: 2927
• Secondary ID: H3E-MC-JMDO
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: April 29, 2002
• Last updated: July 18, 2006

Study information

• Verified date: July 2006
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Pregnancy

• Breast feeding

• Inability to interrupt aspirin therapy

• Brain metastasis

• Patients who have been treated previously with ALIMTA or irinotecan

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Drug:
• ALIMTA

• irinotecan

Locations

Country	Name	City	State
Germany	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	Nordrhein-Westfalen
Germany	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	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	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	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	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.	Munchen
United States	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	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	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

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

United States,  Germany,