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

ID: NCT00034502
Status: Completed
Phase: Phase 1/Phase 2
Start Date: N/A
First Submitted: April 29, 2002
Last Updated: July 18, 2006
Results: N/A
Organization: Eli Lilly and Company
Sponsors & Collaborators: Eli Lilly and Company
Location: Germany, United States
Conditions: Colorectal Cancer
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Study Description

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.

Detailed Description

Condition or disease Intervention/treatment Phase

Colorectal Cancer

Drug: ALIMTA
Other Names
Drug: irinotecan
Other Names
Phase 1/Phase 2

Tracking Information

First Submitted DateApril 29, 2002
Last Update Posted DateJuly 18, 2006
Start DateN/A
Completion DateN/A
Primary Completion DateN/A
Results First Submitted DateN/A
Received Results Disposit DateN/A

Current Primary Outcome Measures

Not Available

Original Primary Outcome Measures

Not Available

Current Secondary Outcome Measures

Not Available

Original Secondary Outcome Measures

Not Available

Study Design

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

Detailed Description

Study TypeInterventional
Study PhasePhase 1/Phase 2
Estimated Enrollment
0
Allocation
Not Available
Interventional Model
Not Available
Masking
Not Available
Primary Purpose
Treatment
Conditions
Colorectal Cancer
Target Follow-Up Duration N/A
Biospecimen:
N/A
Sampling MethodN/A
Study PopulationN/A
Intervention
Drug: ALIMTA

Other Names
Drug: irinotecan

Other Names
Study Groups/Cohorts
Not Available
Study Arms
Not Available
Arm Intervention/Treatment

Recruitment Information

Recruitment Status:Completed
Enrollment0
Completion DateN/A
Eligibility Criteria: 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
GenderAll
Age18 Years to N/A
Accepts Healthy VolunteersNo
Contacts
Not Available
Listed Location Countries
Germany
United States

Administrative Information

NCT Number:NCT00034502
Other Study ID Numbers
2927
H3E-MC-JMDO
Has Data Monitoring CommitteeNo
U.S. FDA-regulated Product Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement
Not Available
Responsible PartyN/A
Study Sponsor
Eli Lilly and Company
Collaborators
Not Available
Investigators
Not Available