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Main
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Note: This record shows only the 20 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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17 October 2012 |
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Main ID: |
NCT00303745 |
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Date of registration:
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15/03/2006 |
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Primary sponsor: |
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Public title:
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Irinotecan With or Without Capecitabine as Second-Line Therapy in Treating Older Patients With Progressive, Metastatic Colorectal Cancer That Cannot Be Removed By Surgery
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Scientific title:
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Randomized Study of Second-Line Therapy Comprising Irinotecan With or Without Capecitabine in Patients Aged At Least 75 Years With Colorectal Cancer |
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Date of first enrolment:
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June 2006 |
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Target sample size:
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78 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00303745 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
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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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Emmanuel Mitry, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hopital Ambroise Pare |
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Name:
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Thomas Aparicio |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hopital Bichat - Claude Bernard |
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Key inclusion & exclusion criteria
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DISEASE CHARACTERISTICS:
- Histologically confirmed metastatic adenocarcinoma of the colon or rectum
- Unresectable disease
- Documented progressive disease during first-line/palliative chemotherapy
- Measurable disease = 1 cm that is outside prior radiation field
- No brain metastases
PATIENT CHARACTERISTICS:
- WHO performance status 0-2
- Life expectancy = 3 months
- No contraindication to chemotherapy
- Creatinine clearance = 40 mL/min
- Absolute neutrophil count = 1,500/mm^3
- Platelet count = 100,000/mm^3
- Alkaline phosphatase = 3 times normal (5 times normal if hepatic involvement)
- Bilirubin = 1.5 times normal
- Transaminases = 5 times normal
- No symptomatic coronary disease or cardiac insufficiency
- No enteropathy or chronic diarrhea
- No unresolved intestinal occlusion or subocclusion
- No history of severe unexpected reaction to a fluoropyrimidine
- No other active malignancy in the past 2 years
- No hypersensitivity to irinotecan hydrochloride or its excipients
- No hypersensitivity to capecitabine or fluorouracil
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior extensive resection
- No concurrent sorivudine or similar analogs (e.g., brivudine)
- No other concurrent anticancer therapy
- Concurrent radiotherapy allowed for nontarget lesions
Age minimum:
75 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Colorectal Cancer
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Intervention(s)
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Drug: capecitabine
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Drug: irinotecan hydrochloride
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Primary Outcome(s)
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Objective response
[Time Frame: No]
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Stable disease rate
[Time Frame: No]
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Secondary Outcome(s)
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Progression-free and overall survival
[Time Frame: No]
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Quality of life
[Time Frame: No]
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Tolerability
[Time Frame: Yes]
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Secondary ID(s)
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CDR0000453857
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EU-20545
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EUDRACT-2004-004742-40
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FFCD-0305
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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