A Trial of ALIMTA (Pemetrexed) Plus Irinotecan in Patients Who Have Been Previously Treated For Metastatic Colorectal Cancer.
Sponsor
Eli Lilly and Company (Industry)
Overall Status
Completed
CT.gov ID
NCT00034502
Collaborator
(none)
9
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1/Phase 2 |
Study Design
Study Type:
Interventional
Primary Purpose:
Treatment
Outcome Measures
Primary Outcome Measures
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts 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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | 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 | |
| 2 | 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 | |
| 3 | 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 | |
| 4 | 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 | |
| 5 | 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 | ||
| 6 | 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 | ||
| 7 | 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 | ||
| 8 | 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 | ||
| 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. | Munchen | Germany |
Sponsors and Collaborators
- Eli Lilly and Company
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00034502
Other Study ID Numbers:
- 2927
- H3E-MC-JMDO
First Posted:
Apr 30, 2002
Last Update Posted:
Jul 19, 2006
Last Verified:
Jul 1, 2006