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Pemetrexed Plus a Comparator Versus a Combination of 2 Comparators in First-Line Treatment of Colorectal Cancer
This study has been completed.
Sponsor:
Eli Lilly and Company
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00079872
First received: March 17, 2004
Last updated: November 5, 2007
Last verified: November 2007
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Purpose
In this study, patients will receive either pemetrexed plus irinotecan or 5-fluorouracil (5-FU), leucovorin, and irinotecan.
The purposes of this study are to determine:
- How pemetrexed plus irinotecan compares with 5-FU, leucovorin, and irinotecan in terms of efficacy.
- The safety of pemetrexed plus irinotecan and any side effects that might be associated with it as compared with 5-FU, leucovorin, and irinotecan.
- Whether pemetrexed can help patients with colorectal cancer.
| Condition | Intervention | Phase |
|---|---|---|
| Colorectal Cancer | Drug: Pemetrexed | Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Factorial Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Randomized Phase 2 Trial of ALIMTA Plus a Comparator Versus Leucovorin Modulated Fluorouracil Plus a Comparator in First Line Treatment of Locally Advanced or Metastatic Colorectal Cancer |
Resource links provided by NLM:
Further study details as provided by Eli Lilly and Company:
Primary Outcome Measures:
- The primary objective is to compare the antitumor activity of pemetrexed plus a comparator with that of leucovorin modulated 5 FU plus a comparator as measured by tumor response rate for patients with locally advanced or metastatic colorectal cancer
Secondary Outcome Measures:
- The secondary objectives of the study are as follows:
- to assess the following time to event efficacy endpoints for patients in both treatment arms:
- overall survival
- progression free survival
- duration of response
- to characterize the quantitative and qualitative toxicities of both treatment arms in this patient population
| Estimated Enrollment: | 120 |
| Study Start Date: | February 2004 |
| Study Completion Date: | May 2006 |
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
The patient must have:
- Histologic or cytologic diagnosis of adenocarcinoma of the colon or rectum.
- Performance status of 0 to 2 on the ECOG Performance Status Scale.
- Standard postoperative adjuvant radiation therapy for rectal cancer is allowed.
- Locally advanced or metastatic disease.
- Must be 18 years of age.
Exclusion Criteria:
The patient must not have:
- Received prior chemotherapy for advanced disease. Prior adjuvant therapy, including 5-FU, is allowed if it has been more than 12 months since the last treatment.
- Received prior treatment with irinotecan in the adjuvant setting.
- Are unable to take vitamin B12 or folic acid.
- Are unable to interrupt aspirin, other nonsteroidal anti-inflammatory drugs, or COX-2 inhibitors for a 5-day period.
- Have a second primary malignancy except carcinoma in situ of the cervix or nonmelanomatous skin cancer, unless that prior malignancy was diagnosed and definitively treated at least 5 years previously with no subsequent evidence of recurrence.
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00079872
Please refer to this study by its ClinicalTrials.gov identifier: NCT00079872
Locations
| Australia, Victoria | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician | |
| NSW, QLD, South Australia, Victoria, Australia | |
| Australia | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician | |
| Woodville, Australia | |
| Germany | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician | |
| Frankfurt/Main, Germany | |
| Greece | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician | |
| Krete, Greece | |
| Netherlands | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician | |
| Amsterdam, Netherlands | |
| Spain | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician | |
| Sevilla, Spain | |
Sponsors and Collaborators
Eli Lilly and Company
Investigators
| Study Director: | Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company |
More Information
Additional Information:
| ClinicalTrials.gov Identifier: | NCT00079872 History of Changes |
| Other Study ID Numbers: |
2929 H3E-MC-JMAZ |
| Study First Received: | March 17, 2004 |
| Last Updated: | November 5, 2007 |
Additional relevant MeSH terms:
|
Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases |
Intestinal Diseases Rectal Diseases Pemetrexed Antineoplastic Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Folic Acid Antagonists Nucleic Acid Synthesis Inhibitors |
ClinicalTrials.gov processed this record on June 22, 2017