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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: |
NCT00209625 |
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Date of registration:
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13/09/2005 |
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Primary sponsor: |
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Public title:
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Phase I / II Study of Irinotecan (CPT-11) Combined With l-Leucovorin (l-LV) and 5-FU in Patients With Advanced Colorectal Cancer
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Scientific title:
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Phase I / II Study of Irinotecan (CPT-11) Combined With l-Leucovorin (l-LV) and 5-FU in Patients With Advanced Colorectal Cancer:Hokkaido Gastrointestinal Cancer Study Group:HGCSG0001 |
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Date of first enrolment:
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April 2000 |
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Target sample size:
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23 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00209625 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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Japan
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Contacts
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Name:
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Masahiro Asaka, 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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Hokkaido Gastrointestinal Cancer Study Group |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Histological diagnosis of colorectral adenocarcinoma.
2. Measurable or assessable lesions.
3. Age: 18 ~ 75 years.
4. Performance Status (ECOG): 0 ~ 2.
5. No prior chemotherapy. Adjuvant chemotherapy is not defined as previous therapy.
6. No history of radiotherapy to the abdomen.
7. Adequate function of major organs (bone marrow, heart, lungs, liver etc.). WBC
3,500/mm3 and 12,000/mm3. Hb 10.0 g/dl. Platelet count 100,000/mm3. GOT and GPT
2.5times the upper limit of normal (excluding liver metastasis). T-Bil 2.0mg/dl.
Creatinine <1.5 mg/dl Normal ECG (not considering clinically unimportant
arrhythmias and ischemic changes).
8. Predicted survival for >3 months.
9. Able to give written informed consent.
Exclusion Criteria:
1. Severe pleural effusion or ascites.
2. Metastasis to the central nervous system (CNS).
3. Active gastrointestinal bleeding.
4. Active infection.
5. Diarrhea (watery stools).
6. Uncontrolled ischemic heart disease.
7. Serious complications (such as intestinal paralysis, intestinal obstruction,
interstitial pneumonia or pulmonary fibrosis, uncontrolled diabetes mellitus, heart
failure, renal failure, or hepatic failure).
8. Active multiple cancer.
9. Severe mental disorder.
10. Pregnancy, possible pregnancy, or breast-feeding.
11. Flucytosine treatment
12. Gilbert’s syndrome.
13. Judged to be ineligible for this protocol by the attending physician.
Age minimum:
18 Years
Age maximum:
75 Years
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: fluorouracil
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Drug: irinotecan
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Drug: leucovorin
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Primary Outcome(s)
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objective tumor response
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Secondary Outcome(s)
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Response duration, time to progression, median survival time, and safety
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Secondary ID(s)
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HGCSG0001
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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