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| Sponsored by: |
Eli Lilly and Company |
|---|---|
| Information provided by: | Eli Lilly and Company |
| ClinicalTrials.gov Identifier: | NCT00034502 |
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Colorectal Cancer |
Drug: ALIMTA Drug: irinotecan |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Kansas | |
| 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 | |
| United States, New York | |
| 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 | |
| United States, Pennsylvania | |
| 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 | |
| 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. | |
| 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. | |
| 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. | |
| 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. | |
| Munchen, Germany | |
| Germany, Nordrhein-Westfalen | |
| 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 | |
More Information
| Study ID Numbers: | 2927, H3E-MC-JMDO |
| Study First Received: | April 29, 2002 |
| Last Updated: | July 18, 2006 |
| ClinicalTrials.gov Identifier: | NCT00034502 |
| Health Authority: | United States: Food and Drug Administration |
|
Folic Acid Pemetrexed Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Irinotecan |
Colonic Diseases Gastrointestinal Neoplasms Intestinal Diseases Rectal Diseases Intestinal Neoplasms Colorectal Neoplasms |
|
Antimetabolites Neoplasms Antimetabolites, Antineoplastic Neoplasms by Site Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |
Therapeutic Uses Enzyme Inhibitors Folic Acid Antagonists Antineoplastic Agents, Phytogenic Pharmacologic Actions |
