Status:
COMPLETED
A Study of the Combination of Pemetrexed and Irinotecan Every Two Weeks in Metastatic Colorectal Cancer
Lead Sponsor:
Eli Lilly and Company
Conditions:
Metastatic Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
A non-randomized phase II study to determine the efficacy and safety of the combination of Pemetrexed and Irinotecan every two weeks in metastatic colorectal cancer patients.
Eligibility Criteria
Inclusion
- Diagnosis of metastatic colorectal adenocarcinoma that is not amenable to curative therapy.
- Patient must have at least one unidimensionally measurable lesion.
- Prior radiation therapy to less than 25% of bone marrow. Radiation must be completed at least 4 weeks prior to study enrollment.
- Performance status 0 to 2
- Patient must have received 1 prior course of chemotherapy (Folfox regimen) for metastatic disease
Exclusion
- Treatment with any drug within the last 30 days that has not received regulatory approval.
- Serious systemic disorder (cardiac or pulmonary disease, active infection)
- Documented brain metastases not amenable to surgery or unstable after radiation
- Inability or unwillingness to take folic acid or Vitamin B12 supplementation.
- Presence of fluid retention that can not be controlled by drainage.
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2008
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT00191984
Start Date
June 1 2004
End Date
May 1 2008
Last Update
January 5 2011
Active Locations (5)
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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) Mon - Fri from 9 AM to 5 PM Eastern time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
Angers, France
2
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
Lille, France
3
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
Montfermeil, France
4
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
Paris, France