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

NCT ID: NCT00034502

Last Updated: 2006-07-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Study Classification

INTERVENTIONAL

Brief Summary

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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.

Detailed Description

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Conditions

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Colorectal Cancer

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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ALIMTA

Intervention Type DRUG

irinotecan

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Locations

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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

Site Status

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

Site Status

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

Site Status

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

Site Status

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

Site Status

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

Site Status

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

Site Status

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

Site Status

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

Site Status

Countries

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United States Germany

Other Identifiers

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H3E-MC-JMDO

Identifier Type: -

Identifier Source: secondary_id

2927

Identifier Type: -

Identifier Source: org_study_id