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

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00034502
Enrollment
Unknown
Registered
2002-04-30
Start date
Unknown
Completion date
Unknown
Last updated
2006-07-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer

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.

Interventions

DRUGALIMTA
DRUGirinotecan

Sponsors

Eli Lilly and Company
Lead SponsorINDUSTRY

Study design

Primary purpose
TREATMENT

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Countries

Germany, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026