Phase I / II Study of Irinotecan (CPT-11) Combined With l-Leucovorin (l-LV) and 5-FU in Patients With Advanced Colorectal Cancer

Study Overview
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Brief Summary
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We performed a phase I/II study of CPT-11/5FU/l-LV in advanced colorectal cancer, to determine the optimal dose of CPT-11 and to estimate the safety and efficacy of this regimen

Detailed Description
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A multicenter Open-label, single-arm, phase I/II clinical trial is conducted on patients with histological stage IV colorectal cancer given irinotecan, leucovorin plus fluorouracil. The usefulness of this regimens as 1st line therapy for colorectal cancer was evaluated by the disease-free survival rate (DFR), median survival time (MST), incidence and severity of adverse event.

Official 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

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Drug: irinotecan
* Drug: leucovorin
* Drug: fluorouracil


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histological diagnosis of colorectral adenocarcinoma. Measurable or assessable lesions. Age: 18   75 years. Performance Status (ECOG): 0   2. No prior chemotherapy. Adjuvant chemotherapy is not defined as previous therapy. No history of radiotherapy to the abdomen. 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). Predicted survival for >3 months. Able to give written informed consent. Exclusion Criteria: Severe pleural effusion or ascites. Metastasis to the central nervous system (CNS). Active gastrointestinal bleeding. Active infection. Diarrhea (watery stools). Uncontrolled ischemic heart disease. Serious complications (such as intestinal paralysis, intestinal obstruction, interstitial pneumonia or pulmonary fibrosis, uncontrolled diabetes mellitus, heart failure, renal failure, or hepatic failure). Active multiple cancer. Severe mental disorder. Pregnancy, possible pregnancy, or breast-feeding. Flucytosine treatment Gilbert's syndrome. Judged to be ineligible for this protocol by the attending physician.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: irinotecan|nan|
|Drug: leucovorin|nan|
|Drug: fluorouracil|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| objective tumor response |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response duration, time to progression, median survival time, and safety |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Irinotecan, leucovorin, fluorouracil, PhaseI/II, colorectal cancer,