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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT00191984 |
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Date of registration:
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12/09/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A Study of the Combination of Pemetrexed and Irinotecan Every Two Weeks in Metastatic Colorectal Cancer
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Scientific title:
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Open Multicenter Phase II Study in Second-Line Metastatic Colorectal Cancer Patients: Combination of ALIMTA and Irinotecan Administered Every Two-Weeks |
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Date of first enrolment:
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June 2004 |
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Target sample size:
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46 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00191984 |
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Study type:
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Interventional |
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Study design:
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Phase:
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Phase 2
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Countries of recruitment
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France
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Contacts
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Name:
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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) |
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Address:
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Telephone:
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Email:
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Affiliation:
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Eli Lilly and Company |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 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 Criteria:
- 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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Metastatic Colorectal Cancer
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Intervention(s)
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Drug: irinotecan
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Drug: pemetrexed
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Primary Outcome(s)
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Best Overall Tumor Response
[Time Frame: baseline to measured progressive disease (up to 2 years follow-up)]
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Secondary Outcome(s)
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Duration of Response
[Time Frame: time of response to progressive disease or death (up to 2 years follow-up)]
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Time to Treatment Failure
[Time Frame: baseline to stopping treatment (up to 2 years follow-up)]
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Progression-Free Survival (PFS)
[Time Frame: baseline to measured progressive disease or death (up to 2 years follow-up)]
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Overall Survival
[Time Frame: baseline to date of death from any cause (up to 2 years follow-up)]
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Secondary ID(s)
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H3E-FP-S057
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8673
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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