Status:
COMPLETED
Pemetrexed Plus a Comparator Versus a Combination of 2 Comparators in First-Line Treatment of Colorectal Cancer
Lead Sponsor:
Eli Lilly and Company
Conditions:
Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 irinot...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2004
Trial Type :
INTERVENTIONAL
End Date :
May 1 2006
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00079872
Start Date
February 1 2004
End Date
May 1 2006
Last Update
November 6 2007
Active Locations (6)
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1
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
2
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
3
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 am Main, Germany
4
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